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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 23rd, 2020 12:00AM
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REGIONAL ACCOUNT MANAGER - ST. LOUIS, MO
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Open
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Oct 19th, 2020 12:00AM
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<div>
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<p><strong>Job Summary:</strong></p><p>Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. </p><p><strong>Essential Duties & Responsibilities</strong></p><ul><li>Meet all quarterly sales objectives for Supernus products within designated territory</li><li>Implement marketing and sales strategies as directed</li><li>Participate in off-site sales meetings and training programs as required</li><li>Demonstrate mastery of selling skills as outlined in the Initial Sales Training program and subsequent Plan of Action (P.O.A.) meetings</li><li>Demonstrate advanced knowledge of Supernus products, competitive products, and support services</li><li>Demonstrate effective interaction with all company personnel</li><li>Maintain up-to-date call records for physicians and other key customers</li><li>Follow company policies for distribution of marketing material and samples</li><li>Submit reports and paperwork accurately and on time</li><li>Maintain a professional, business-like appearance at all times</li><li>Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers</li><li>Assist with special projects as assigned by management (i.e. managed care pull-through programs, pre-launch initiatives, customer support outside of designated territory/territories, etc.)</li><li>Develop and maintain a positive business climate for the Company</li><li>Consult with Management on unusual problems or situations</li><li>Read and follow the Company’s policies and procedures</li></ul><p><strong> </strong></p><p><strong>Knowledge & Other Qualifications:</strong></p><ul><li>A minimum of a Bachelor’s degree (B. A. or B.S.) from a four-year college or university </li><li>3+ years of successful outside sales experience required</li><li>Previous Business-to-Business Sales experience required</li><li>2-5 years of pharmaceutical or medical sales preferred (Neurology/CNS experience is a plus) </li><li>Must possess excellent organization, interpersonal and communication skills</li><li>Must demonstrate sound judgment and decision-making ability</li><li>Must be proficient with Excel, Word, Outlook, PowerPoint (Microsoft office)</li><li>Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures.</li></ul><p><strong> </strong></p><p><strong>Other Requirements:</strong></p><ul><li>Travel required, including overnight stays (up to 30%-70% depending on assigned territory)</li><li>May be required to work evenings and weekends as needed</li><li>Individuals must live near the center of their territory or be willing to relocate to it </li><li>Individuals must produce documented sales results and examples of awards/achievements</li><li>Field sales staff must hold a valid driver’s license </li><li>Capable of performing other duties as assigned by management</li><li>Authorized to legally work in the United States without visa sponsorship</li></ul><p>Physical Requirements / Work Environment:</p><ul><li>Lifting Requirements: Exerting up to 20 pounds of force frequently to pick up, move and/or carry objects; i.e., marketing materials, product samples, etc.</li><li>Walking: Intermittent walking and moving about from location to location</li><li>Visual Acuity: to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal and for operating motor vehicles</li><li>Driving and Travel: Must be able to drive during the week day and be able to travel up to 50% </li><li>Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.</li></ul><p> </p><p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</p><p> #CB</p>
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Oct 23rd, 2020 07:02AM
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Oct 23rd, 2020 07:02AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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REGIONAL ACCOUNT MANAGER - ST. LOUIS, MO
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Open
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Oct 19th, 2020 12:00AM
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<div><div>
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<p><strong>Job Summary:</strong></p><p>Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. </p><p><strong>Essential Duties & Responsibilities</strong></p><ul><li>Meet all quarterly sales objectives for Supernus products within designated territory</li><li>Implement marketing and sales strategies as directed</li><li>Participate in off-site sales meetings and training programs as required</li><li>Demonstrate mastery of selling skills as outlined in the Initial Sales Training program and subsequent Plan of Action (P.O.A.) meetings</li><li>Demonstrate advanced knowledge of Supernus products, competitive products, and support services</li><li>Demonstrate effective interaction with all company personnel</li><li>Maintain up-to-date call records for physicians and other key customers</li><li>Follow company policies for distribution of marketing material and samples</li><li>Submit reports and paperwork accurately and on time</li><li>Maintain a professional, business-like appearance at all times</li><li>Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers</li><li>Assist with special projects as assigned by management (i.e. managed care pull-through programs, pre-launch initiatives, customer support outside of designated territory/territories, etc.)</li><li>Develop and maintain a positive business climate for the Company</li><li>Consult with Management on unusual problems or situations</li><li>Read and follow the Company’s policies and procedures</li></ul><p><strong> </strong></p><p><strong>Knowledge & Other Qualifications:</strong></p><ul><li>A minimum of a Bachelor’s degree (B. A. or B.S.) from a four-year college or university </li><li>3+ years of successful outside sales experience required</li><li>Previous Business-to-Business Sales experience required</li><li>2-5 years of pharmaceutical or medical sales preferred (Neurology/CNS experience is a plus) </li><li>Must possess excellent organization, interpersonal and communication skills</li><li>Must demonstrate sound judgment and decision-making ability</li><li>Must be proficient with Excel, Word, Outlook, PowerPoint (Microsoft office)</li><li>Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures.</li></ul><p><strong> </strong></p><p><strong>Other Requirements:</strong></p><ul><li>Travel required, including overnight stays (up to 30%-70% depending on assigned territory)</li><li>May be required to work evenings and weekends as needed</li><li>Individuals must live near the center of their territory or be willing to relocate to it </li><li>Individuals must produce documented sales results and examples of awards/achievements</li><li>Field sales staff must hold a valid driver’s license </li><li>Capable of performing other duties as assigned by management</li><li>Authorized to legally work in the United States without visa sponsorship</li></ul><p>Physical Requirements / Work Environment:</p><ul><li>Lifting Requirements: Exerting up to 20 pounds of force frequently to pick up, move and/or carry objects; i.e., marketing materials, product samples, etc.</li><li>Walking: Intermittent walking and moving about from location to location</li><li>Visual Acuity: to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal and for operating motor vehicles</li><li>Driving and Travel: Must be able to drive during the week day and be able to travel up to 50% </li><li>Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.</li></ul><p> </p><p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</p><p> #CB</p>
</div>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 23rd, 2020 12:00AM
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SENIOR CLINICAL PROGRAM MANAGER
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Open
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Rockville, MD, US
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Rockville
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MD
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USA
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Sep 21st, 2020 12:00AM
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<div><div><div><p> </p>
<p><strong>Job Summary:</strong></p>
<p>To provide leadership, direction, strategy, and execution of necessary protocols in the Clinical Operations department.</p>
<p><strong>Essential Duties & Responsibilities</strong></p>
<ul>
<li dir = "auto">Partners with Clinical Research and Operations leads to successfully plan and implement clinical trials for assigned programs.</li>
<li dir = "auto">Oversees vendor selection and management, including request for proposal, day-to-day operations, timeline supervision, study document generation, contract negotiation, budget management, etc.</li>
<li dir = "auto">Forecasts study budget and actively manages in collaboration with finance department.</li>
<li dir = "auto">Serves as Clinical Operations Lead in project team meetings. </li>
<li dir = "auto">Ensures compliance with protocol and applicable regulations/GCPs.</li>
<li dir = "auto">Contributes to the development of the Target Product Profile for assigned studies. </li>
<li dir = "auto">Works collaboratively with Clinical Operations and Research leads, and other functional area project team members.</li>
<li dir = "auto">Leads in process improvement initiatives to ensure best industry standards and approaches.</li>
<li dir = "auto">Participates in resource planning, including identification of resource options across the assigned programs and resource analysis across the assigned programs. </li>
<li dir = "auto">Reviews departmental SOP’s that are newly generated or revised, and oversees the implementation of finalized SOP’s.</li>
</ul>
<p><strong>Non-Essential Duties & Responsibilities:</strong></p>
<ul>
<li dir = "auto">Presents at meetings such as Investigator Meetings.</li>
<li dir = "auto">Coaches and mentors staff.</li>
<li dir = "auto">Participates in special initiatives, as assigned.</li>
</ul>
<p><strong>Supervisory Responsibilities:</strong></p>
<ul>
<li dir = "auto"> May provide leadership to Clinical Research Associates.</li>
</ul>
<p><strong>Knowledge & Other Qualifications:</strong></p>
<ul>
<li dir = "auto"> Minimum of BS/BA in a biomedical discipline, or equivalent education/training is required.</li>
<li dir = "auto">BS with 10 years of experience in related field, or MS with 5 - 7 years of experience in related field, or Doctorate with 3 - 5 years of experience in related field (Ph.D/MD/PharmD/DVM).</li>
<li dir = "auto">At least 5 years clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.</li>
<li dir = "auto">Leadership, clinical project management, administrative, and technical capabilities are required.</li>
<li dir = "auto">Effective verbal and written communication skills.</li>
<li dir = "auto">Direct experience in clinical pharmacology/experimental medicine research studies/programs preferred.</li>
</ul>
<p><strong>Other Characteristics:</strong></p>
<ul>
<li dir = "auto">Ability to work independently and as part of a team.</li>
<li dir = "auto">Ability to maintain high ethical standards of integrity and quality.</li>
<li dir = "auto">Capable of being innovative and dynamic in approach to work.</li>
<li dir = "auto">Capable of performing other duties as assigned by management.</li>
<li dir = "auto">Authorized to legally work in the United States without visa sponsorship.</li>
</ul>
<p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</p>
<p></p>
<p>#CB</p>
</div></div></div>
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Oct 23rd, 2020 07:02AM
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Oct 23rd, 2020 07:02AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 23rd, 2020 12:00AM
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SENIOR DYNAMICS AX ADMINISTRATOR
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Open
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Rockville, MD, US
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Rockville
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MD
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USA
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Sep 28th, 2020 12:00AM
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<div><div><div><div><div><link href="https://cdn.jsdelivr.net/npm/froala-editor@3.1.1-1/css/froala_editor.pkgd.min.css" rel="stylesheet" type="text/css"> <link href="https://cdn.jsdelivr.net/npm/froala-editor@3.1.1-1/css/froala_style.min.css" rel="stylesheet" type="text/css"><div class="fr-view"><div><div><div><div><p> </p><p><strong>Job Summary: </strong></p><p>The Microsoft Dynamics AX Administrator is responsible for on-going maintenance/development of the Supernus Dynamics AX 2012 R3 ERP while ensuring compliance with SOX 404 regulations. Additionally, this position will create and maintain IT policies and procedures relating to Dynamics AX, as well as, proposing and/or collaborating on enhancements with outside departments. Negotiation of on-going care contracts with 3<sup>rd</sup> party Dynamics AX vendors may be required.</p><p><strong>**This position is an in-house role. ***</strong></p><p><strong>Essential Duties & Responsibilities</strong></p><ul type="disc"><li>Development and maintenance of custom security roles.</li><li>User access provisioning and de-provisioning.</li><li>SSRS report development.</li><li>Ensuring compliance with SOX 404 Regulations as it pertains to Information Technology General Controls.</li><li>Management and review of: <ul type="circle"><li>Code releases.</li><li>Segregation of duties.</li><li>Security logs.</li></ul></li><li>Ability to generate and execute SQL queries.</li><li>Liaise with third party system support to troubleshoot and resolve issues.</li></ul><p> </p><p><strong>Non-Essential Duties & Responsibilities:</strong></p><ul><li>Ability to apply knowledge of infrastructure security when making decisions with regard to system configuration.</li></ul><p><strong>Supervisory Responsibilities:</strong></p><ul><li> N/A</li></ul><p><strong>Knowledge & Other Qualifications:</strong></p><ul><li>Bachelor’s Degree preferred or equivalent experience.</li><li>4+ years relevant experience with 3+ years of experience with Microsoft Dynamics AX (2012 R3 or previous version) in the manner described above.</li><li>Must have experience with SOX Compliance.</li><li>Installing and configuring SharePoint, preferred</li></ul><p><strong>Other Characteristics:</strong></p><ul><li>Ability to work independently and as part of a team.</li><li>Capable of being innovative and dynamic in approach to work.</li><li>Capable of performing other duties as assigned by management.</li><li>Authorized to legally work in the United States without visa sponsorship.</li></ul><p><strong>Physical Requirements / Work Environment:</strong></p><ul><li>Sedentary work. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.</li><li>The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; and extensive reading</li><li>The worker is not substantially exposed to adverse environmental conditions</li></ul><p> </p><p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</p></div></div></div></div></div></div></div></div></div></div>
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Oct 23rd, 2020 07:02AM
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Oct 23rd, 2020 07:02AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 23rd, 2020 12:00AM
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QUALITY ASSURANCE ASSOCIATE II
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Open
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Full Time
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 15th, 2020 12:00AM
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<p></p>
<p> </p>
<p> </p>
<p> <span style="color: black;background-color: transparent;font-size: 9pt;font-family: Georgia;"><strong>Job Summary:</strong></span> </p>
<p><span style="color: black;background-color: transparent;font-size: 16px;font-family: Georgia;">To support the Company’s Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, and performing inspections of GMP facilities, and mastering CFR and/or FDA guidance.</span> </p>
<p style="margin-left:0in;"> </p>
<p style="margin-left:0in;"> <span style="background-color: transparent;font-size: 9pt;font-family: Georgia;"><strong>Essential Duties & Responsibilities (Skills & Abilities):</strong></span> </p>
<ul>
<li style="margin-left:0.25in;" dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Major responsibilities include reviewing GMP documentation, line clearances, status control of Raw Materials and Finish Product, participate in internal audits; keeping the information well organized and in a state of inspectional readiness; maintaining record integrity and security; and retrieving and auditing on-site record documentation</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Maintain the QA compliance systems in accordance with U.S. Regulations and internal standards</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Maintain the Quality Assurance compliance systems in accordance with U.S. Regulations and internal standards</span> <span style="background-color: transparent;font-size: 16px;font-family: Georgia;">·</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Perform critical phase inspections related to GMP manufacturing, and/or GCP and/or GLP studies</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Perform review of documents related to GMP and/or GLP and/or GCP activities; may act as liaison for commercial project with vendor.</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Participate in external audit of suppliers and vendors</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">When appropriate, assist in all FDA inspections regarding Supernus regulated activities</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">When appropriate, assist in internal audit procedures at Supernus</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Assist in the preparation, execution, report and follow-up of internal and external audits</span> <span style="background-color: transparent;font-size: 16px;font-family: Georgia;">·</span> <span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Support senior staff members in their responsibilities and tasks; assist in month-end reports, tracking and trending.</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Initiate new SOPs or revise existing SOPs for the QA department as needed</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Stay current with CFR and/or FDA guidance documents to ensure that Supernus’ compliance policies are up to date</span> </li>
</ul>
<p><span style="background-color: transparent;font-size: 14px;font-family: Georgia;"><strong>Non-Essential Duties & Responsibilities (Skills & Abilities):</strong></span><span style="font-size: 14px;"> </span> </p>
<ul>
<li style="margin-left:0.25in;" dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">May review SOPs subject to Quality Assurance review</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">May serve as a backup for Training activities, regarding general compliance to the Quality Assurance department responsibilities</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">May serve as a backup for Documentation Management activities, regarding general compliance to the Quality Assurance department responsibilities and maintaining company’s SOP systems</span> </li>
</ul>
<p style="margin-left:0in;"> <span style="background-color: transparent;font-size: 9pt;font-family: Georgia;"><strong>Supervisory Responsibilities:</strong></span> </p>
<ul>
<li style="text-align:justify;" dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">n/a</span> </li>
</ul>
<p> <span style="background-color: transparent;font-size: 9pt;font-family: Georgia;"><strong>Knowledge and Other Qualifications:</strong></span> </p>
<ul>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">B.S. in a life sciences discipline, with 2+ years of experience in GMP and/or GCP and/or GLP environment</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Understanding of cGMPs and/or</span> <span style="background-color: transparent;font-size: 16px;font-family: Georgia;">GCPs and/or GLPs and their application to a wide variety of problems and situations</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Strong communication and technical writing skills in the English language. A second language is a plus</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Ability to work independently, as well as ability to function as a team player, ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Ability to work efficiently and accurately to meet set goals and timelines, and attentive to detail</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Ability to work in a fast paced and flexible work environment where priorities can change</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Familiar with pharmaceutical equipment, utilities, and validation concepts</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Familiar with internal and external auditing is a plus</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Excellent interpersonal and communication skills in English language (writing, speaking, comprehension)</span> </li>
<li dir = "auto"><span style="background-color: transparent;font-size: 16px;font-family: Georgia;">Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF</span> </li>
</ul>
<p style="margin-left:0.25in;"><br> <span style="background-color: transparent;font-size: 11.5pt;font-family: Georgia;">Supernus Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. </span> </p>
<p style="margin-left:0.25in;"> </p>
<p style="margin-left:0.25in;"><span style="font-size: 16px;font-family: Georgia;">#CB</span><br> </p>
<p style="margin-left:0.25in;"><br> </p>
<p style="margin-left:0.25in;"><br> </p>
<p> </p>
<p style="margin-left:0.25in;"> </p>
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Oct 23rd, 2020 07:02AM
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Oct 23rd, 2020 07:02AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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GMP SPECIALIST I
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Open
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Full Time
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 15th, 2020 12:00AM
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<div><div><div><div><strong> </strong></div><div><strong>Job Summary:</strong><span class="Apple-tab-span" style="font-size: medium; white-space: pre;"> </span> </div><div>To perform various manufacturing tasks and activities including but not limited to writing SOPs for equipment and processes, maintaining equipment, and execution of cGMP batch records and developmental experiments.<span class="Apple-tab-span" style="white-space:pre;"> </span> </div><div> </div><div><strong>Essential Duties & Responsibilities:</strong><span class="Apple-tab-span" style="font-size: medium; white-space: pre;"> </span> </div><div>Responsible for performing a wide variety of manufacturing tasks and experiments as follows: </div><div>·Will perform operation, set-up, disassembly and cleaning of pharmaceutical equipment for developmental work and cGMP manufacturing. This includes maintaining inventories of equipment change parts, spare parts, etc. Assist in maintaining record keeping for inventory, equipment calibrations and preventive maintenance.</div><div>·Execution of cGMP batch records and developmental experiments using laboratory notebooks, which includes use of Good Documentation Practices.</div><div>·Work closely within Pharmaceutical Sciences (primarily with Drug Delivery Sciences, Technology Development, and Pharmaceutical Analysis) to complete projects as assigned.</div><div>·Perform troubleshooting, repair, maintenance and calibration of applicable manufacturing equipment, which includes auxiliary support equipment.</div><div>·Perform routine inspection, calibration, and maintenance of safety and environmental equipment, and/or coordinating contracted services for such tasks. May act as liaison for contractors performing equipment and facility maintenance. </div><div>·Assist in Safety activities as needed.</div><div>·Perform validation of equipment.</div><div>·Write SOPs for applicable equipment, processes, and safety and environmental procedures.</div><div>·Identify compliance issues with regard to internal procedures, and perform administrative duties for regulatory paperwork.</div><div>·Cleaning of processing rooms as necessary, and keeping laboratory safety areas organized.</div><div>·May make detailed observations, analyze data and interpret results. </div><div>·Maintains equipment and inventory levels for supplies. </div><div>·May write experimental reports, summaries and protocols. </div><div>·Assist with cGMP warehouse operations as needed. </div><div>·Maintain and repair cGMP suite and warehouse as necessary, which includes minor repairs, painting, etc.<span class="Apple-tab-span" style="white-space:pre;"> </span> </div><div><br></div><div> </div><div><strong>Knowledge and Other Qualifications:</strong><span class="Apple-tab-span" style="white-space: pre;"> </span> </div><div>·High School Diploma or equivalent + 3 years or College Degree 0+ years.</div><div>·Requires knowledge of cGMPs and other commonly used concepts, practices, and procedures within the pharmaceutical industry</div><div>·Knowledge of solid dosage form manufacturing including but not limited to; encapsulation, manufacture of compressed tablets, fluid bed processing, high shear granulation, tablet coating, blending, etc</div><div>·Mechanical skills with regard to operation, maintenance and calibration of pharmaceutical manufacturing equipment</div><div>·Ability to work independently by gathering information and problem solving GMP & Safety issues in a manufacturing/packaging environment</div><div>·Knowledge of safety and environmental regulations</div><div>·Ability to write and adhere to internal written procedures</div><div>·Ability to work with hazardous waste and laboratory chemicals</div><div>·Some heavy lifting (around 50 pounds) is required<span class="Apple-tab-span" style="white-space:pre;"> </span> </div><div> </div><div><strong><span style="line-height: 0.909093;">Other Characteristics:</span><span class="Apple-tab-span" style="line-height: 0.909093; white-space: pre;"> </span></strong><span style="line-height: 0.909093;"><strong> </strong> </span></div><div>·Ability to work independently and as part of a team</div><div>·Maintain high ethical standards of integrity and quality</div><div>·Capable of being innovative and dynamic in approach to work</div><div>·Capable of performing other duties as assigned by management</div><div>·Authorized to legally work in the United States without visa sponsorship<span class="Apple-tab-span" style="white-space:pre;"> </span> </div><div><br></div><div><p class="msonormal"><span>Supernus Pharmaceuticals is an Equal Opportunity /
Affirmative Action employer. All qualified applicants will receive
consideration for employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, protected veteran
status, age or any other characteristic protected by law.</span></p><br></div><div><br></div><div><br></div></div></div></div>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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ASSOCIATE DIRECTOR, ANALYTICAL SCIENCES
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Open
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 15th, 2020 12:00AM
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<div><p>Job Summary </p><p>To manage Preformulation Sciences activities including but not limited to API characterization, method development, method validation, writing procedures/protocols and technical reports and preparation of regulatory documents. To train, develop, supervise, and provide leadership to PFS junior staff. </p><p>Essential Duties & Responsibilities: </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Oversee and provide key elements of AnalyticalSciences support for the drug substances of all projects at Supernus (API characterization, method development and validation, testing, reports) </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Manage the release of raw materials for manufacturing activities conducted at Supernus </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Manage and provide leadership & guidance to junior staff in an effective manner consistent with corporate objective </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Manage training and development of staff </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Maintain a broad knowledge of scientific principles and theories </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Plan and manage laboratory research, such as solubility and compatibility studies </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Overseee activities performed at contract laboratories for API characterization and API/raw materials testing </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Interact with other departments and outside contractors </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Prepare or review CMC sections relevant to raw materials, API and packaging components of Regulatory Submissions </p><p>Non-Essential Duties & Responsibilities: </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Assist with troubleshooting of laboratory equipment. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Update written procedures (SOPs) related to PFS activities when needed. </p><p>Supervisory Responsibilities: </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Supervise junior technical staff </p><p>Knowledge and Other Qualifications: </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Requires a degree in Chemistry or Pharmaceutical Science with commensurate experience: Ph.D. with 10+ years relevant experience, MS with 14+ years relevant experience. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Well-versed in instrumental methods, techniques and theory used in pharmaceutical analysis (HPLC, spectroscopy, wet chemistry and physical testing). </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Expertise with regulatory fillings is a plus </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Strong technical expertise skills related to API characterization are essential (e.g., polymorhism, solubility,…) </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Strong, interpersonal, communication, and leadership skills. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Excellent technical writing skills are essential. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Strong laboratory documentation skills and GMP experience. </p><p>Other Characteristics: </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Ability to work independently and as part of a team. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Ability to maintain high ethical standards of integrity and quality. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Dynamic and innovative in approach to work. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Capable of performing other duties as assigned by management. </p><p style="margin-left:0.25in;"><span style="font-family: Symbol;">·</span> Authorized to legally work in the United States without visa sponsorship. </p><p> </p><p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.<br> </p></div>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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DIRECTOR, CONTRACTS AND PRICE REPORTING
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Open
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 15th, 2020 12:00AM
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<div><p></p>
<p><span style="font-size: 10pt;"><strong>Job Summary: </strong></span> </p>
<p style="text-align:justify;"><span style="font-size: 10pt;">The three primary areas of focus for this position are contract development, compliance, and contract performance measurement.</span> <span style="font-size: 10pt;">The Director, Contracts and Price Reporting will work closely with field-based and internal personnel to develop managed care contract terms and conditions.</span> <span style="font-size: 10pt;">This position will build and evaluate financial models in support of potential contract proposals.</span> <span style="font-size: 10pt;">This position is also responsible for ensuring compliance with all managed care contractual terms as well as applicable laws and regulations related to government pricing.</span> </p>
<p><span style="font-size: 10pt;"><strong>Essential Duties & Responsibilities:</strong></span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Leads operational activities including rebates, chargebacks, government reporting, contract writing and process approvals</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Provides contracting expertise across multiple segments including commercial, Medicaid and Medicare Part D</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Create effective processes/controls to track contract terms which support efficient operations and ensures implementation of contract strategies</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops and negotiates managed care agreement terms and conditions</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Collaborates with internal stakeholders including Finance, Marketing, Sales Operations, Medical Affairs, Legal and other groups with primary focus on compliance, forecasting and optimizing contract performance</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Responsible for the monitoring and reporting of contract effectiveness related to assigned accounts, utilizing pre and post deal modeling </span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops contract performance metrics such as assessment of market share, Rx volume growth tracking, and profitability. Measures impact of payer contracts versus corporate financial operating plans. </span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops deep understanding of competitive market conditions that affect pricing for marketed products</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Interprets impacts of evolving market conditions and makes recommendations on pricing and contract strategies related to managed care, reimbursement, and government reporting requirements</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Primary direct interface with National Account Management on contract development</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops analytical tools to calculate the impact of Price Transparency Laws on in-line portfolio and pipeline products </span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Works collaboratively with Legal and Compliance to interpret price transparency laws related to potential pricing activity</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops and maintains SOP’s and other documentation to ensure compliance with all federal and state price transparency laws</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Present to senior leadership the impact of price action scenarios to Transparency Law reporting requirements</span> </p>
<p> </p>
<p style="margin-left:0in;"><span style="font-size: 10pt;"><strong>Supervisory Responsibilities:</strong></span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="color: rgb(74,74,74);background-color: white;font-size: 10pt;">Leadership: Establishes an environment where they lead their group by exhibiting the behaviors required to be successful. Demonstrates an ability to listen to all points of view, synthesize the information and create team buy-in for the solution. Ability to lead the execution of the solution/strategy.</span> </p>
<p> </p>
<p><span style="font-size: 10pt;"><strong>Knowledge & Other Qualifications:</strong></span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Bachelor’s degree, (Master’s Degree preferred)</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">10+ years related experience. 5+ years of pharmaceutical industry experience</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Deep understanding/expertise in U.S. market access dynamics</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to influence without authority</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Strong analytical skills including problem solving, forecasting, contract development and financial modelling</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Demonstrated negotiation & relationship building skills</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Demonstrated ability to manage multiple priorities</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Strong oral and written communication skills, including a strong focus on customer service</span> </p>
<p> </p>
<p><span style="font-size: 10pt;"><strong>Other Characteristics:</strong></span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Authorized to legally work in the United States without visa sponsorship.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to work independently and as part of a team.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to maintain high ethical standards of integrity and quality.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Capable of being innovative and dynamic in approach to work. </span> </p>
<p> </p>
<p><span style="font-size: 10pt;"><strong>Physical Requirements/Work Environment/Travel Requirements: </strong></span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">The worker is not substantially exposed to adverse environmental condition</span> </p>
<h1><span style="font-size: 10pt;font-family: Calibri, sans-serif;">Competencies:</span> </h1>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Professionalism/Dependability</strong>:</span> <span style="font-size: 10pt;">Work is accomplished quickly and accurately, uses time efficiently.</span> <span style="font-size: 10pt;">Demonstrates attention to detail.</span> <span style="font-size: 10pt;">Follows policies, procedures and instructions, responds to management direction.</span> <span style="font-size: 10pt;">Accepts responsibility for own actions.</span> <span style="font-size: 10pt;">Demonstrates accountability for the objectives that are in their area of responsibility.</span> <span style="font-size: 10pt;">Treats others with respect and consideration regardless of their status or position. Supports the organization’s goals and values. Manages competing demands.</span> <span style="font-size: 10pt;">Adapts to changes in the work environment.</span> <span style="font-size: 10pt;">Demonstrates persistence and overcomes obstacles, remaining positive and focused.</span> <span style="font-size: 10pt;">Exhibits sound and accurate judgment.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Customer Focus:</strong></span> <span style="font-size: 10pt;">Demonstrates knowledge of internal and external customers and understands their needs; builds and maintains effective internal and external customer relationships; responds promptly to customer needs.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Job Knowledge:</strong></span> <span style="font-size: 10pt;">Demonstrates competence in required job skills and knowledge; collects, researches and synthesizes complex or diverse information using intuition and experience to complement data; Understands the U.S. payer landscape and is able to communicate this information to colleagues with differing levels of managed market knowledge.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Problem Solving:</strong></span> <span style="font-size: 10pt;">Gathers and analyzes information skillfully; recommends implements and evaluates courses of action; identifies and resolves problems in a timely manner; develops and presents project alternatives and recommendations to achieve objectives. Proven ability to identify issues and provide effective solutions to address them.</span> <span style="font-size: 10pt;">Ability to effectively communicate the solution and its value to affected parties.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Interpersonal/Communication Skills:</strong></span> <span style="font-size: 10pt;">Establishes and maintains positive working relationships with customers, suppliers, supervisors, peers, subordinates; focuses on solving conflict, not blaming, using tact and diplomacy to handle difficult situations; speaks clearly and persuasively in positive and negative situations; writes clearly and informatively, varying writing style to meet needs, demonstrates effective presentation skills in individual and/or group situations. Strong presentation and communication skills that can deliver clear concise messages to a variety of internal and external customers.</span> </p>
<p style="margin-left:0.25in;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Teamwork and Collaboration:</span> <span style="font-size: 10pt;">Balances team and individual responsibilities; exhibits objectivity and openness to others' ideas and tries new things; gives and welcomes feedback; able to accomplish objectives while building morale and group commitments to goals and objectives.</span> </p>
<p style="text-align:justify;"><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;"><strong>Strategic Thinking:</strong></span> <span style="font-size: 10pt;">Develops and recommends strategies to achieve organizational goals; understands organization’s competencies, strengths and weaknesses; identifies external threats and opportunities; adapts strategy to changing conditions.</span> </p>
<p> </p>
<p><span style="font-size: 10pt;">Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</span> </p>
<p>#CB </p>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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ASSOCIATE DIRECTOR, BIOSTATISTICS
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Open
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 15th, 2020 12:00AM
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<div><p><span style="font-size: 10pt;">Job Summary</span> </p>
<p><span style="color: black;background-color: white;font-size: 10pt;">The Associate Director of Biostatistics is responsible for directing the biostatistics activities for clinical studies sponsored by Supernus Pharmaceuticals Inc. from trial design, execution, analysis, and data interpretation.</span><span style="font-size: 10pt;"> Works cooperatively with the Director, in the development of<br>Standard Operating Procedures (SOPs). Develops statistical methods sections of protocols. </span> </p>
<p><span style="font-size: 10pt;">Essential Duties & Responsibilities:</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Contributes in study level tasks from statistics perspective: selection of study design, selection of end points to meet research objectives, sample size and power<br>calculation, and analyses methods.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops or review SAPs, TLF shell and specification, and review CRF’s and other study documentations</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> Performs ad hoc statistical analyses, including the statistical programming, for assigned studies; interprets data and provides statistical input to clinical protocols, Clinical Study Reports (CSR). </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Lead and/or manage both in-house and CRO activities related to statistical analysis, programming and data management.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Performs simulations to create mock analyses. Proposes new/novel statistical methodological approaches to improve the efficiency and sensitivity of study<br>results. </span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Interacts with staff from other operational groups (clinical research, clinical OPs, marketing<br>and preclinical).</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Develops biostatistics and data management SOP’s.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Provides effective guidance and communicates to CRO staff in the production of tables, figures, and listings.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Reviews and validates analysis data sets, tables, figures, and listings. </span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Reviews database design, CRF’s, and edit checks.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Attends FDA advisory committee meeting.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Reviews and prepares Integrated Safety (ISS) and Integrated Summary Efficacy (ISE).</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Reviews CDISC/SDTM and DEFINE.XML.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Attends Operations meetings, keeps up-to-date on project issues companywide, and keeps Director informed of project issues.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Works under limited supervision.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Assists with other duties as assigned.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Interacts with clients as needed for project and/or relationship management.</span> </p>
<p><span style="font-size: 10pt;">Non-Essential Duties & Responsibilities:</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">N/A</span> </p>
<p><span style="font-size: 10pt;">Supervisory Responsibilities:</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Provides oversight to the data capture and management, and database requirements.</span> </p>
<p><span style="font-size: 10pt;">Knowledge and Other Qualifications:</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ph.D. with 6+ plus years of experience or MS in Biostatistics with 8+ for Associate years of experience in the pharmaceutical/CRO (Associate) , including significant<br>interactions with regulatory bodies and experience in central nervous system indication preferred.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Broad knowledge and superior understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, sensitivity analysis. </span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Fluent in SAS data step programming including SAS macro, familiarity with other packages (e.g., nQuery Advisor, R).</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Familiarity with ICH guideline and FDA other regulatory authority guidance.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Excellent written and oral communication skills including grammatical/technical writing skills.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Excellent attention and accuracy with details.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Familiarity with statistical methods that apply to Phase I-IV clinical trials.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Strong organizational skills.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to solve moderately complex problems (identify, propose & implement<br>solutions).</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to work in team situations.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Demonstrated strong individual initiative.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to effectively manage multiple tasks and projects.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to lead and co-ordinate the work of small teams.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to work in a fully self-directed manner</span> </p>
<p><span style="font-size: 10pt;">Other Characteristics:</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Authorized to legally work in the United States without visa sponsorship.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors,<br>customers and others.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to work independently and as part of a team.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Ability to maintain high ethical standards of integrity and quality.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Capable of being innovative and dynamic in approach to work. </span> </p>
<p><span style="font-size: 10pt;">Physical Requirements / Work Environment</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects.<br>Sedentary work involves sitting most of the time.</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer<br>screen, iPad, or other electronic device; and extensive reading</span> </p>
<p><span style="font-size: 10pt;font-family: Symbol;">·</span> <span style="font-size: 10pt;">The worker is not substantially exposed to adverse environmental conditions</span> </p>
<p><span style="font-size: 10pt;">Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard<br>to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic<br>protected by law.</span> <br> </p>
<p> </p>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:supn
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www.supernus.com
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workforcenow.adp.com
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Oct 24th, 2020 12:00AM
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CALIBRATION ASSISTANT I
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Open
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Full Time
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Rockville, MD, US
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Rockville
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MD
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USA
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Oct 23rd, 2020 12:00AM
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<div><div><div class="WordSection1"><p>Job Summary</p><p>Responsible for the calibration, qualification and preventative maintenance of all laboratory instruments/equipment for the Analytical Sciences (AS) and Quality Control (QC) departments</p><p>Essential Duties & Responsibilities:</p><ul><li>Calibrates and/or reviews calibration a variety of laboratory instruments/equipment to ensure compliance with specifications (e.g., HPLCs, dissolution units, Karl Fisher units, environmental chambers).</li><li>Performs routine installation, qualification, maintenance, repair, and calibration on laboratory equipment.</li><li>Coordinate and assist contractors who may be used to perform any of the above tasks. </li><li>Investigate and troubleshoot out of calibration results.</li><li>Responsible for maintaining the calibration database</li><li>On call 24/7 to respond to environmental chamber excursions</li></ul><p>Non-Essential Duties & Responsibilities:</p><ul><li>Provide calibration and/or instrument use training to laboratory personnel, as applicable.</li><li>Write qualification documents for laboratory instrumentation.</li><li>Update and/or create written procedures (SOPs) concerning instrumentation when needed. </li></ul><p>Supervisory Responsibilities:</p><ul><li>N/A</li></ul><p>Knowledge and Other Qualifications:</p><ul><li>B.S. in Chemistry, Engineering or other relevant degree with 0+ years of experience or high school degree or relevant technical school training/certification with 2+ years of relevant experience.</li><li>Ability to calibrate a variety of laboratory instruments while ensuring compliance with specifications.</li><li>Ability to understand and follow written procedures concerning laboratory instrumentation.</li><li>Strong organizational skills with attention to detail.</li><li>Excellent interpersonal and communication skills.</li><li>Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.</li><li>GMP experience a plus.</li></ul><p>Other Characteristics:</p><ul><li>Ability to work independently and as part of a team.</li><li>Ability to maintain high ethical standards of integrity and quality.</li><li>Dynamic in approach to work.</li><li>Capable of performing other duties as assigned by management.</li><li>Authorized to legally work in the United States without visa sponsorship.</li></ul><p>Physical Requirements / Work Environment:</p><ul><li>Position may requires prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination</li><li>The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; and extensive reading</li><li>The worker is not substantially exposed to adverse environmental conditions</li><li>Will be required to work in a clean laboratory environment, and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, lab coats, and when applicable dust masks.</li></ul><p> </p><p>Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.</p> </div><span style='font-size:12px;line-height:115%;
font-family:"Calibri",sans-serif;'><br style="page-break-before:always;"></span></div></div>
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Oct 24th, 2020 04:34AM
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Oct 24th, 2020 04:34AM
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Supernus Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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