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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 23rd, 2019 12:00AM
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Senior Manager/Associate Director, Chemical Development
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Open
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Technical Operations
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Full-Time
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South San Francisco
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California
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USA
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Oct 17th, 2018 12:00AM
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<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">We’re seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader wiling to contribute to overall CMC development strategy and in particular contribute to chemical development strategy in support of late phase developmental programs at Principia. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities. This position reports into the Senior Director of Chemical Development.</p>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">A more complete description of the position, and experience required, is listed below:</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>POSITION PURPOSE: </span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">• Phase appropriate process development and characterization of chemical manufacturing process is implemented to produce and deliver APIs and their starting materials and intermediates, for use in manufacturing of clinical trial materials in a timely manner<br>• Oversight of contract manufacturing organizations conducting process development studies according to Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identified proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge-of-failure (EoF), characterization of APIs to identify critical quality attributes (CQAs). Provide direction to the CROs in terms of design of chemical development strategies during clinical development and design of registration strategies for commercial supply chain(s), review and approval of release testing data, as well as stability data. Review of quality control testing and certification that batches meet specifications and in compliance with GMP; and document and institutionalize all development activities as source materials for regulatory filings<br>• Design chemical development strategy that is phase-appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization<br>• Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) is applied for CMC development strategy and chemical development, and effectively communicate to functional groups across all levels of the organization and competent authorities.</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"> </h3>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>JOB DESCRIPTION</span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">This role will provide leadership and management in the planning and execution of chemical development activities. The candidate must be accomplished (demonstrated by experience and successes, with at least one successful validation of chemical development plan for commercialization) with the applications of chemical development expertise and as an expert in the field, and will function as Principia’s chemical development representative at contract research/manufacturing organizations. The candidate will lead Principia in the innovation and development of Principia’s chemical development strategy for technical operations. The candidate will be responsible for: leading phase-appropriate development and validation of manufacturing process; reviewing and approving quality control test results; and applying expert knowledge in regulatory/cGMP requirements in responses to requests for information from competent authorities. The candidate will work with cross-functional projects and lead the design and execution of chemical development strategies. A willingness to work in the lab to solve process chemistry issue is highly desired.</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"> </h3>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>QUALIFICATIONS</span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">Minimum of Bachelor’s degree (ideally in Chemistry or Chemical Engineering) in a technical field: PhD with 8+ years of industrial chemical development experience is preferred, Master’s degree with 10+ years of experience, or Bachelor’s degree with 15+ years of experience. The successful candidate is familiar with current manufacturing processes and equipment used in chemical development and validation. Previous experience in API manufacturing of small molecule, early to late phase development is required. Strong and independent problem-solving, ability to troubleshoot especially relevant to process chemistry issues is a must. Experienced in devising chemical development strategy in compliance with regulatory/cGMP requirements (for US and EU Directive, US and ICH regulatory guidance). Prior experience with IND/IMPD and NDA/MAA submissions are required.</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"> </h3>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>EXPERIENCE AND SKILLS</span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">The candidate will have proven leadership, and in depth knowledge of a broad spectrum of chemical development and regulatory documentation and submission, and demonstrated successes in qualifying or validating as appropriate for the stage of development. Strong knowledge and demonstrated practice of broad array of chemical processing equipment, including familiarity with supporting analytical instrumentation such as HPLC, UV/Vis spectroscopy, mass spectrometry, moisture analysis by Karl Fischer, etc. and their application. Experience with drug substance solid forms and characterization of physical and chemical properties are also desired. Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships. Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure. Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.</p>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif"> </p>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">Principia Biopharma, Inc. is an equal opportunity employer.</p>
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Jan 23rd, 2019 01:01PM
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Jan 23rd, 2019 01:01PM
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Principia Biopharma
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 23rd, 2019 12:00AM
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Medical Writer
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Open
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Regulatory
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Contractor
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South San Francisco
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California
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USA
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Oct 25th, 2018 12:00AM
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<p><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Medical Writer</span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">This is a medical writers position that requires use of scientific knowledge and writing skills to effectively and clearly communicate. This position requires focus on scientific medical writing, which includes medical studies, drug trials and regulatory documents. </span></p>
<p><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Responsibilities: </span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Work with cross functional teams and conduct literature searches to enhance their background understanding, and evaluate and analyze the information they will be writing about.</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">It ensures that all deliverables are in accordance with regulations, standards, and guidelines. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">The regulatory documents that the Medical Writer prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Must understand the levels of evidence required to achieve regulatory, marketing and regulatory goals</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Responsible compilation, writing, and editing medical and regulatory writing covering all phases of clinical research for submission to regulatory agencies or Ethics committees (i.e. clinical study reports, create summary or changes, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data, publications, etc).</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Conduct adjudication meetings, maintain version control and insure timelines are agreed upon and met.<span> </span></span></p>
<p><b><span style="color: #181717;font-family: 'Arial',sans-serif"> </span></b><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Medical Writer Skills</span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">At least 10 year of experience in pharmaceutical development or related experience</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Proficiency in Word, Excel, PowerPoint, email, and the Internet</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Extensive knowledge of English grammar with a familiarity with a standard style guide</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to communicate scientific or medical information in a clear and concise manner</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Familiarity with the principles of clinical research</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to interpret and present clinical data and other complex information</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">A strong communicator with meticulous attention to detail solid writing and organizational skills. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to work well independently or as part of a team including in high-pressure situations. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Collaborative, ability to influence and reach compromises cross functionally to reach a quality document </span></p>
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Jan 23rd, 2019 01:01PM
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Jan 23rd, 2019 01:01PM
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Principia Biopharma
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|
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 23rd, 2019 12:00AM
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Associate Director, Supply Chain
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Open
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Technical Operations
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Full or Contract
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South San Francisco
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California
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USA
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Dec 4th, 2018 12:00AM
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<p><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">About Principia:</span></b></p>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Principia Biopharma is a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency<sup>®</sup> platform enables the Company to design and develop reversible and irreversible covalent, small molecule inhibitors with potencies and selectivities that have the potential to rival those of injectable biologics, yet maintain the convenience of a pill. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenic purpura, a rare hematological disease. PRN2246, a low dose covalent BTK inhibitor which crosses the blood-brain barrier, is being developed for multiple sclerosis and, potentially, for other diseases of the central nervous system. It has completed dosing in a Phase 1 clinical trial in healthy volunteers and has been partnered to Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor, or FGFR, is being evaluated in a Phase 1 trial in patients with solid tumors.<b></b></span></p>
<p><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"> </span></b></p>
<p><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Job Description:</span></b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<ul>
<li>Reporting to the Dire<span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">ctor of Supply Chain, this individual </span><span style="color: black;font-size: 11.0pt;font-family: 'Calibri',sans-serif">will be accountable for the commercial supply chain set up in preparation for product launch and commercialization. This role is a unique opportunity for an experienced Supply Chain and CMO management leader to shape the supply chain strategy and drive the execution necessary to produce and deliver the company’s first commercial product.</span><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"> <span>The individual will partner closely with CMC, Quality, Program Leadership and Regulatory and must be able to easily flex from executive level discussions to day-to-day management of commercial supply chain operations; the role is both strategic and hands on. </span></span><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">The individual must have the ability to work independently and be an effective team member in a fast-paced environment.</span>
</li>
</ul>
<p style="text-align: justify"><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"> </span></b></p>
<p style="text-align: justify"><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Abilities:</span></b></p>
<ul type="disc">
<li>D<span style="font-size: 11pt;font-family: Calibri, sans-serif">evelop the strategy for all commercial supply chain activities, including capacity/capability, sourcing,</span><span style="font-size: 11pt;font-family: Calibri, sans-serif"> </span><span style="font-size: 11pt;font-family: Calibri, sans-serif">and inventory</span><span style="font-size: 11pt;font-family: Calibri, sans-serif"> </span><span style="font-size: 11pt;font-family: Calibri, sans-serif">recommendations</span>
</li>
<li>Oversee supply chain aspects of GMP manufacturing at CMOs, including contracts, purchase orders, production planning, overall performance and tracking of day to day<span style="font-size: 11pt;font-family: Calibri, sans-serif"> </span><span style="font-size: 11pt;font-family: Calibri, sans-serif">activities</span>
</li>
<li>Lead the commercial packaging and labeling of the product through packaging design, shipping validation, and implementation of artwork; includes GMP oversight and person-in-plant activities for packaging and labeline</li>
<li><span style="color: black;font-size: 11.0pt;font-family: 'Calibri',sans-serif">Drive the distribution strategy, 3PL selection, internal serialization set up and oversee the supply chain/distribution networks, including monitoring, tracking and optimizing inventory</span></li>
<li>Oversee all import, export, brokerage, storage and transportation for key raw materials, drug<span style="font-size: 11pt;font-family: Calibri, sans-serif"> </span><span style="font-size: 11pt;font-family: Calibri, sans-serif">substance, drug product and finished goods</span>
</li>
<li>Oversee state pharmaceutical licensing program for distribution </li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Support in activities for clinical packaging and labeling, including but not limited to label/package design, primary and secondary packaging, development of IRT specfications, distribution and inventory management</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Review departmental SOPs and ensure updates and compliance with industry standards</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Partner with and develop strong internal collaboration with stakeholders, such as Chemical, Formulation and Analytical Development, Clinical Operations, Regulatory Affairs, Quality, and Project Management functions, to ensure high customer satisfaction</span></li>
<li style="text-align: justify">
<span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Contributes to the operational excellence of supply chain management at Principia</span><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span>
</li>
</ul>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<p><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<p style="text-align: left"><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"> </span></b></p>
<p style="text-align: left"><b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Minimum Qualifications:</span></b><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif"></span></p>
<ul type="disc">
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">At least 5 years of experience in clinical supply management and/or manufacturing functions in the pharmaceutical or medical device industry</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Experience with forecasting, distribution and import/export regulations </span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Demonstrated skills in project management and CMO vendor management</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Working knowledge of drug development process and current GXP guidance</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Leadership skills, maturity, composure, emotional intelligence</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Ability to perform in a fast-paced environment with competing priorities under tight deadlines</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Proficient with Microsoft Office (e.g. Project, Word, PowerPoint, Excel, Outlook, Visio)</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Experience within a start-up biotech company a plus</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">Bachelor’s Degree required.<span> </span>Scientific degree preferred.<span> </span>Advanced degree (Science, MBA) is a plus.</span></li>
<li><span style="font-size: 11.0pt;font-family: 'Calibri',sans-serif">APICS certification or supply chain education is a plus</span></li>
</ul>
<p><span style="font-size: 10.0pt;font-family: 'Arial',sans-serif">Principia Biopharma, Inc. is an equal opportunity employer.<span style="color: black"></span></span></p>
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Jan 23rd, 2019 01:01PM
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Jan 23rd, 2019 01:01PM
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Principia Biopharma
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 23rd, 2019 12:00AM
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Senior Scientist Chemical Development
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Open
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Chemical Development
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Full-Time
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South San Francisco
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California
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USA
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Dec 17th, 2018 12:00AM
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<p style="text-align: justify"><span><b><span style="color: black;font-family: 'Arial',sans-serif">Position Purpose:<span> </span></span></b></span></p>
<ul>
<li> <span style="font-family: 'Arial',sans-serif">Phase appropriate process development and characterization of chemical manufacturing process is implemented to produce and deliver APIs and their starting materials and intermediates, for use in manufacturing of clinical trial materials in a timely manner</span>
</li>
<li><span style="font-family: 'Arial',sans-serif">Oversight of contract manufacturing organizations and serve as the person in plant during manufacture and help to troubleshoot should issues arise. </span></li>
<li>Perform process characterization studies according to the principles of Quality by Design (QbD).<span style="text-align: justify;font-family: Arial, sans-serif"> </span><span style="text-align: justify;font-family: Arial, sans-serif">This include a one-variable-at-time (OVAT) and DOE studies to identify the proven acceptable ranges (PARs) of the critical process parameters (CPPs) in efforts to link to the API critical quality attributes (CQAs).</span>
</li>
<li>Review of quality control testing and certification that batches meet specifications and in compliance with GMP; and document and institutionalize all development activities as source materials for regulatory filings<span style="text-align: justify;font-family: Arial, sans-serif"> </span>
</li>
<li>Perform specification justification studies to establish limits of APIs, intermediates and regulatory starting materials</li>
<li><span style="font-family: 'Arial',sans-serif">Effectively communicate to cross functional groups (chemical development, analytical, Quality, program management and regulatory).</span></li>
</ul>
<p style="text-align: justify"><span><b><span style="color: black;font-family: 'Arial',sans-serif">Job Description:<span> </span></span></b></span><span style="font-family: 'Arial',sans-serif">This is an individual contributor role involved in the execution of chemical development activities. The candidate must have shown a history of accomplishments as demonstrated by prior experiences and prior successes with at least one late stage chemical development program through the ability to identify and solve problems in a timely manner.<span> </span>The candidate will be able to support both early stage and late stage development programs which includes reviewing and approving quality control documents and test results. The candidate will work with cross-functional teams and will have the opportunity to lead the design and execution of chemical development activities. When needed, the candidate will be expected to travel to contract research/manufacturing organizations and will function as Principia’s chemical development representative. </span></p>
<p style="text-align: justify"><b><span style="color: black;font-size: 11.0pt;font-family: 'Arial',sans-serif">Qualifications</span></b><b><span style="color: black;font-size: 11.0pt;font-family: 'Arial',sans-serif">:</span></b><span style="color: black;font-size: 11.0pt;font-family: 'Arial',sans-serif"><span> </span>M</span><span style="font-size: 11.0pt;font-family: 'Arial',sans-serif">inimum of Bachelor’s degree (ideally in Chemistry or Chemical Engineering) in a technical field: PhD with at least 5 years of industrial chemical development experience is preferred, Master’s degree with at least five years of experience, or Bachelor’s degree with at least eight years of experience. The successful candidate is familiar with current manufacturing processes and equipment used in chemical development and validation. Previous experience in API manufacturing of small molecule, early to late phase development is required. Strong and independent problem-solving, ability to troubleshoot especially relevant to process chemistry issues is required.<span> </span>Experienced in devising chemical development strategy in compliance with regulatory/cGMP requirements is a desired. Prior experience with IND/IMPD and NDA/MAA submissions area are also desired.</span></p>
<p style="text-align: justify"><b><span style="color: black;font-family: 'Arial',sans-serif">Experience and Skills: </span></b><span style="font-family: 'Arial',sans-serif">The candidate will a strong knowledge of process chemistry and demonstrated practice of broad array of chemical processing equipment, including familiarity with supporting analytical instrumentation such as HPLC, UV/Vis spectroscopy, mass spectrometry, moisture analysis by Karl Fischer, etc. and their application. Experience with drug substance solid forms and characterization of physical and chemical properties are desired. Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships. Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure. Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment. </span></p>
<p style="text-align: justify"><span style="font-family: 'Arial',sans-serif">Principia Biopharma, Inc. is an equal opportunity employer.<span style="color: black"></span></span></p>
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Jan 23rd, 2019 01:01PM
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Jan 23rd, 2019 01:01PM
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Principia Biopharma
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 23rd, 2019 12:00AM
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Director/Sr. Director Pharmaceutical Technology
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Open
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Technical Operations
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Full-Time
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South San Francisco
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California
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USA
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Dec 22nd, 2018 12:00AM
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<p><b><span style="font-family: 'Times New Roman',serif">Job Summary:</span></b></p>
<p><span style="font-family: 'Times New Roman',serif">The Director/Senior Director, Pharmaceutical Technology position is responsible for leading and executing Phase 3 to commercial drug product (bulk and packaged solid oral dosage NME products) development plan, characterization for tech transfer and validation for commercialization. </span></p>
<p><span style="font-family: 'Times New Roman',serif"> </span></p>
<p><b><span style="font-family: 'Times New Roman',serif">Responsibilities:</span></b></p>
<ul type="disc">
<li><span style="font-family: 'Times New Roman',serif">Lead and manage all activities related to Phase 3 CMC drug product development activities and tech transfer, ensuring that (1) appropriate scientific and technical standards are established; (2) data are available to support regulatory filing; and (3), in partnership with Quality, quality controls are implemented and followed.</span></li>
<li>Provide technical and project leadership to ensure success through to commercialization.</li>
<li>Lead and manage CMO activities for late stage development (e.g. tech transfer, scale-up/process development/optimization and from process validation through commercialization).</li>
<li><span style="font-family: 'Times New Roman',serif">Oversight of contract manufacturing organizations conducting process characterization studies according to the principles of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identified proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge-of-failure (EoF), characterization of input materials (active pharmaceutical ingredients and excipients) to identify critical quality attributes (CQAs). Provide direction to the CMOs in terms of design of formulation characterization studies during clinical development and design of registration strategies for commercial supply chain(s), review and approval of release testing data, as well as stability data. Review of quality control testing and certification that batches meet specifications and in compliance with GMP; and document and institutionalize all development activities as source materials for regulatory filings.</span></li>
<li><span style="font-family: 'Times New Roman',serif">Author and review validation related documents and process development reports.</span></li>
<li><span style="font-family: 'Times New Roman',serif">Actively contribute to writing key pharmaceutical development sections of regulatory documents IND/IMPD/NDA.</span></li>
<li><span style="font-family: 'Times New Roman',serif">Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.</span></li>
<li><span style="font-family: 'Times New Roman',serif">Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements.</span></li>
<li><span style="font-family: 'Times New Roman',serif">Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.</span></li>
</ul>
<p><span style="font-family: 'Times New Roman',serif"> </span></p>
<p><b><span style="font-family: 'Times New Roman',serif">Requirements:</span></b></p>
<ul>
<li>Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering (or related discipline) with 15+ years of industry experience, or demonstrated track record of successfully validating solid oral dosage drug products.</li>
<li>MS degree in related scientific discipline with 20+ years industry experience.</li>
<li><span style="font-family: 'Times New Roman',serif">Well-versed and demonstrated successes in the application of QbD principles.</span></li>
<li>Demonstrated success in shepherding late phase oral drug product through pharmaceutical development characterization to validation, pre-approval inspection and commercial manufacturing.</li>
<li>Excellent knowledge in FDA and EMA regulations and cGMP, ICH guidelines (Q8, Q9, Q12).</li>
<li>Highly skilled in solid oral dosage formulation and process development for immediate release and modified release dosage forms.</li>
<li>Extensive experience managing contract manufacturing organizations is North America, Europe and Asia.</li>
<li>S<span style="font-family: 'Times New Roman', serif">trong leadership, interpersonal, communication, collaboration and problem solving skills along with strengths in delivering results on firm deadlines in support of development programs.</span>
</li>
<li>Have strong organizational and planning skills to determine appropriate resources for resolution of problems.</li>
<li>Ability to travel domestically and internationally up to 25% of the time.</li>
</ul>
<p><span style="font-family: 'Times New Roman',serif"></span></p>
<p>Principia Biopharma, Inc. is an equal opportunity employer.</p>
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Jan 23rd, 2019 01:01PM
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Jan 23rd, 2019 01:01PM
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Principia Biopharma
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 25th, 2019 12:00AM
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Sr. Clinical Data Manager
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Open
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Development Operations
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Contractor
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|
South San Francisco
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California
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USA
|
Oct 1st, 2018 12:00AM
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|
<p><span style="font-size: 12px"><b>The Role</b></span></p>
<p style="text-align: justify"><span style="font-size: 12px">The Clinical Data Manager <span style="color: black">will coordinate clinical data management activities for phase I-IV clinical trials by supervising outside vendors and contractors, as well as performing data quality checks to ensure the integrity of the clinical data. The incumbent ensures that all data management procedures are executed with accuracy and timeliness</span>. </span></p>
<p><span style="font-size: 12px"><b>Essential Responsibilities</b></span></p>
<ul>
<li><span style="font-size: 12px">Oversee clinical data management activities across multiple studies, prepare DM minutes, agendas, data process flow maps and internal timelines</span></li>
<li><span style="font-size: 12px">Assist in the design of the eCRFs and ensure that they conform to Principia’s standards</span></li>
<li><span style="font-size: 12px">Supervise vendors that have been contracted to handle Principia’s data (e.g., EDC and IRT vendors, CROs, Labs, etc.) and ensure the data are complete, accurate and delivered within the timelines agreed to </span></li>
<li><span style="font-size: 12px">Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.</span></li>
<li><span style="font-size: 12px">Perform User Acceptance Testing (UAT) on development of EDC and IRT systems</span></li>
<li><span style="font-size: 12px">Ensure data transfer specifications are in place and review data transfers for consistency with Principia data standards and SDTM specifications</span></li>
<li><span style="font-size: 12px">Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells</span></li>
<li><span style="font-size: 12px">Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document, data plans and as requested by the clinical team.</span></li>
<li><span style="font-size: 12px">Participate in reviews of TFL output prior to final database locks</span></li>
<li><span style="font-size: 12px">Ensure that all data management documentation have been collected and uploaded to the relevant sections of the working files on the server and the study TMF</span></li>
<li><span style="font-size: 12px">Report query trends and data/query metrics and oversee suggest any changes, additional training as appropriate</span></li>
<li><span style="font-size: 12px">Prioritize projects and coordinate data management activities in support of corporate goals and objectives</span></li>
<li><span style="font-size: 12px">Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices</span></li>
<li><span style="font-size: 12px">Address the business needs of CDM functional customers</span></li>
<li><span style="font-size: 12px">Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership.</span></li>
</ul>
<p><span style="font-size: 12px"><b>Qualifications</b></span></p>
<ul>
<li><span style="font-size: 12px">Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies</span></li>
<li><span style="font-size: 12px">Working knowledge of SAS databases and SAS programming</span></li>
<li><span style="font-size: 12px;text-align: justify">Multi-task in a fast paced environment</span></li>
<li><span style="font-size: 12px">Work without close supervision both independently and as part of a team</span></li>
<li><span style="font-size: 12px">Proactively foresee and solve problems and commit to a high level of service</span></li>
<li><span style="font-size: 12px">Build strong cooperative relationships with coworkers</span></li>
<li><span style="font-size: 12px">Work well with people from a variety of different backgrounds and cultures</span></li>
<li><span style="font-size: 12px">Write complex documentation without direct supervision</span></li>
<li><span style="font-size: 12px">Possess a high degree of attention to detail</span></li>
<li><span style="font-size: 12px">Propose solutions and schedule all problem solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints</span></li>
<li><span style="font-size: 12px">Previous employment at a pharmaceutical or biotech company or CRO</span></li>
</ul>
<p><span style="font-size: 12px"><b>Education</b></span></p>
<ul>
<li><span style="font-size: 12px">BA or BS degree with a minimum of 7 years relevant experience in a life science industry; or equivalent combination of education and experience.</span></li>
<li><span style="font-size: 12px">4 years relevant working knowledge of CDISC and SDTM standards</span></li>
</ul>
<p style="text-align: justify"><span style="font-size: 12px"><b>Language skills</b></span></p>
<ul>
<li><span style="font-size: 12px">Superior written and spoken communication skills in English</span></li>
<li><span style="font-size: 12px">Ability to clearly communicate complex issues, observations and resolutions to management</span></li>
</ul>
<p style="text-align: justify"><span style="font-size: 12px"><b>Reasoning ability</b></span></p>
<ul>
<li><span style="font-size: 12px">Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions</span></li>
<li><span style="font-size: 12px">Work on complex problems where the analysis of situations or data requires in-depth evaluation</span></li>
<li><span style="font-size: 12px">May determine methods and procedures on new assignments</span></li>
</ul>
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Jan 25th, 2019 11:54AM
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Jan 25th, 2019 11:54AM
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Principia Biopharma
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|
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nasdaq:prnb
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principiabio.bamboohr.com
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principiabio.bamboohr.com
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Jan 25th, 2019 12:00AM
|
Director, Biostatistics
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Open
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Development Operations
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Full-Time
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South San Francisco
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California
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USA
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Oct 1st, 2018 12:00AM
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|
<p><b>The Role</b></p>
<p><span>The Director Biostatistics will be the statistical lead on Principia clinical development projects. This position will work collaboratively with clinicians, data managers, clinical operations and external CRO statisticians and programmers in the planning, conduct, and analysis of clinical studies in all phases.</span></p>
<p><b><span>Essential Responsibilities</span></b></p>
<ul type="disc">
<li><span>Lead the biostatistics function to develop and execute statistical strategy, design, and analyses for clinical trials</span></li>
<li><span>Direct the activities and manage external CROs and /or statisticians, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards </span></li>
<li><span>Ensure timely delivery CROs of quality analysis results</span></li>
<li><span>Provide guidelines and standards to CROs to ensure quality of deliverables</span></li>
<li><span>Work with department head and colleagues to develop, implement and maintain internal and outsourced biostatistics department standards and practices</span></li>
<li><span>Help design data capture methods and select appropriate study endpoints for clinical programs</span></li>
<li><span>Attend meetings with regulatory agencies and support/defend clinical programs</span></li>
<li><span>Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data</span></li>
<li><span>Be able to conduct independent research and resolve statistical methodological issues</span></li>
<li><span>Ensure that the interpretation of data obtained, from trials conducted by CROs is accurate, scientifically sound and credible</span></li>
<li><span>Supervise internal and external statistical resources to achieve department functional goals for biostatistics and data management</span></li>
<li><span>Responsible for writing statistical methodology section of the protocol, including sample size calculation.</span></li>
<li><span>Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE.</span></li>
<li><span>Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents to ensure critical variables are collected</span></li>
<li><span>Participate in operations meetings and address issues related to biometrics.</span></li>
<li><span>Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.</span></li>
<li>
<span>Perform ad hoc analysis and data validation as needed</span><span>.</span><span></span>
</li>
</ul>
<p><b><span>Qualifications</span></b><span></span></p>
<ul type="disc">
<li><span>Good knowledge of drug development regulations pertinent to statistical analysis</span></li>
<li><span>Experience in contributing to NDAs/BLAs submission and defense successfully with health authorities is preferred</span></li>
<li><span>Proficient SAS programming skills and solid understanding of CDISC models and SDTM and ADAM standards</span></li>
<li><span>Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills</span></li>
<li><span>Extensive knowledge of clinical research methodology and regulatory requirements as they related to trial design and analysis is required; experience in oncology is required.</span></li>
<li><span>Good knowledge of ICH, FDA, and GCP regulations and guidelines</span></li>
<li><span>Has scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.</span></li>
<li><span>Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences </span></li>
</ul>
<p><b><span>Education</span></b></p>
<ul type="disc">
<li><span>PhD in Statistics, Biostatistics, or related fields;</span></li>
<li><span>A minimum of 15 years of experience with at least 3 years of supervisory experience managing an outsourced biometrics function, is preferred</span></li>
</ul>
<p><b><span>Leadership Competencies</span></b></p>
<ul>
<li>Team Builder</li>
<li>Stakeholder Communication & Management</li>
<li>Cultivates Innovation</li>
<li>Drives for Results</li>
<li>Strategic Thinking</li>
<li>Resilient</li>
<li>Ensures Accountability</li>
<li>Drives Engagement and Decision Quality</li>
<li>Manages Ambiguity and Complexity</li>
<li>Optimizes Work Processes</li>
<li>Continuous Learning and Self-Development</li>
</ul>
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Jan 25th, 2019 11:54AM
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Jan 25th, 2019 11:54AM
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Principia Biopharma
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|
|
|
nasdaq:prnb
|
principiabio.bamboohr.com
|
principiabio.bamboohr.com
|
Jan 25th, 2019 12:00AM
|
Senior Director, GCP Quality
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Open
|
Quality
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Full-Time
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|
South San Francisco
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California
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USA
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Oct 17th, 2018 12:00AM
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|
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">Reporting to the Vice President, Quality and Compliance, this position will require regular interaction with senior management and executives on matters concerning the quality and compliance clinical study activities. This individual is expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. He/She will be expected to exercise judgment within broadly defined regulations in selecting systems and evaluation criteria for obtaining results. He/She will ensure budgets, schedules, and performance requirements are met. </p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>PURPOSE:</span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">To establish and manage quality standards, systems and procedures to assure the protection of clinical study subjects, study integrity and compliance with Good Clinical Practice (GCP) regulations. The position will provide quality oversight of clinical study activities.</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>RESPONSIBILITIES:</span></h3>
<h4 style="font-size: 16px;font-family: proxima-nova, arial, sans-serif">Policies, Systems and Procedures:</h4>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">• Establish and maintain appropriate policies and procedures for the conduct of Principia’s clinical studies in collaboration with Clinical and Regulatory colleagues.<br>• Lead, coach, facilitate, and support problem-solving, analysis of data and continuous improvement activities.</p>
<h4 style="font-size: 16px;font-family: proxima-nova, arial, sans-serif">Clinical Study Participation:</h4>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">• Participating in the evaluation and qualification of clinical vendors.<br>• Provide support and proactive strategic planning for QA oversight of clinical development activities.<br>• Assisting clinical development and operations in the development of training materials and conducting training.<br>• Investigation of significant study deviations, creatively finding solutions to complex compliance issues and management of CAPAs.</p>
<h4 style="font-size: 16px;font-family: proxima-nova, arial, sans-serif">Quality Auditing:</h4>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">• Conduct domestic and international clinical vendor audits, participating cross functionally with internal stakeholders to assure compliance with GCP regulations and Principia Standard Operating Procedures (SOPs).<br>• Conduct study audits to assess compliance with GCP requirements, study protocols, manuals, plans and company standards.<br>• Conducting internal quality audits to assess Principia’s GCP compliance.<br>• Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop root cause Corrective and Preventive Action (CAPA) plans.<br>• Maintaining databases for audit observations and CAPAs.<br>Tracking, reviewing, approving, and assessing the effectiveness of CAPAs.</p>
<h4 style="font-size: 16px;font-family: proxima-nova, arial, sans-serif">Competent Authority Inspections:</h4>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">• Facilitate and assist with the preparation, coordination, and management of Competent Authority inspections of Principia and clinical vendors.<br>• Prepare clinical sites for Competent Authority GCP inspections.</p>
<h3 style="color: #f36c00;font-size: 14px;font-family: DINMittelschriftStd, arial, sans-serif"><span>QUALIFICATION REQUIREMENTS:</span></h3>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif">The position requires a bachelors/masters degree in science/nursing; 15+ years of experience in clinical development with an ethical pharmaceutical company with 5+ years of auditing experience; a thorough knowledge of US and EU GCPs; ICH clinical and quality guidelines as well as 21CFR11 requirements. Candidates must demonstrate expert problem solving, organizational, planning, prioritizing, decision-making, as well as exceptional communication (written and oral), negotiation and influencing skills. Strong computer skills in applications used in a general office settings such as word processing, spreadsheets, presentations, data base management, and internet search engine applications is also required. This position may require up to 40% travel.</p>
<p style="color: #757575;font-size: 16px;font-family: proxima-nova, arial, sans-serif"> </p>
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Jan 25th, 2019 11:54AM
|
Jan 25th, 2019 11:54AM
|
Principia Biopharma
|
|
|
|
nasdaq:prnb
|
principiabio.bamboohr.com
|
principiabio.bamboohr.com
|
Jan 19th, 2019 12:00AM
|
Sr. Clinical Data Manager
|
Open
|
Development Operations
|
Contractor
|
|
South San Francisco
|
California
|
USA
|
Oct 1st, 2018 12:00AM
|
|
<p><span style="font-size: 12px"><b>The Role</b></span></p>
<p style="text-align: justify"><span style="font-size: 12px">The Clinical Data Manager <span style="color: black">will coordinate clinical data management activities for phase I-IV clinical trials by supervising outside vendors and contractors, as well as performing data quality checks to ensure the integrity of the clinical data. The incumbent ensures that all data management procedures are executed with accuracy and timeliness</span>. </span></p>
<p><span style="font-size: 12px"><b>Essential Responsibilities</b></span></p>
<ul>
<li><span style="font-size: 12px">Oversee clinical data management activities across multiple studies, prepare DM minutes, agendas, data process flow maps and internal timelines</span></li>
<li><span style="font-size: 12px">Assist in the design of the eCRFs and ensure that they conform to Principia’s standards</span></li>
<li><span style="font-size: 12px">Supervise vendors that have been contracted to handle Principia’s data (e.g., EDC and IRT vendors, CROs, Labs, etc.) and ensure the data are complete, accurate and delivered within the timelines agreed to </span></li>
<li><span style="font-size: 12px">Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.</span></li>
<li><span style="font-size: 12px">Perform User Acceptance Testing (UAT) on development of EDC and IRT systems</span></li>
<li><span style="font-size: 12px">Ensure data transfer specifications are in place and review data transfers for consistency with Principia data standards and SDTM specifications</span></li>
<li><span style="font-size: 12px">Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells</span></li>
<li><span style="font-size: 12px">Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document, data plans and as requested by the clinical team.</span></li>
<li><span style="font-size: 12px">Participate in reviews of TFL output prior to final database locks</span></li>
<li><span style="font-size: 12px">Ensure that all data management documentation have been collected and uploaded to the relevant sections of the working files on the server and the study TMF</span></li>
<li><span style="font-size: 12px">Report query trends and data/query metrics and oversee suggest any changes, additional training as appropriate</span></li>
<li><span style="font-size: 12px">Prioritize projects and coordinate data management activities in support of corporate goals and objectives</span></li>
<li><span style="font-size: 12px">Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices</span></li>
<li><span style="font-size: 12px">Address the business needs of CDM functional customers</span></li>
<li><span style="font-size: 12px">Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership.</span></li>
</ul>
<p><span style="font-size: 12px"><b>Qualifications</b></span></p>
<ul>
<li><span style="font-size: 12px">Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies</span></li>
<li><span style="font-size: 12px">Working knowledge of SAS databases and SAS programming</span></li>
<li><span style="font-size: 12px;text-align: justify">Multi-task in a fast paced environment</span></li>
<li><span style="font-size: 12px">Work without close supervision both independently and as part of a team</span></li>
<li><span style="font-size: 12px">Proactively foresee and solve problems and commit to a high level of service</span></li>
<li><span style="font-size: 12px">Build strong cooperative relationships with coworkers</span></li>
<li><span style="font-size: 12px">Work well with people from a variety of different backgrounds and cultures</span></li>
<li><span style="font-size: 12px">Write complex documentation without direct supervision</span></li>
<li><span style="font-size: 12px">Possess a high degree of attention to detail</span></li>
<li><span style="font-size: 12px">Propose solutions and schedule all problem solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints</span></li>
<li><span style="font-size: 12px">Previous employment at a pharmaceutical or biotech company or CRO</span></li>
</ul>
<p><span style="font-size: 12px"><b>Education</b></span></p>
<ul>
<li><span style="font-size: 12px">BA or BS degree with a minimum of 7 years relevant experience in a life science industry; or equivalent combination of education and experience.</span></li>
<li><span style="font-size: 12px">4 years relevant working knowledge of CDISC and SDTM standards</span></li>
</ul>
<p style="text-align: justify"><span style="font-size: 12px"><b>Language skills</b></span></p>
<ul>
<li><span style="font-size: 12px">Superior written and spoken communication skills in English</span></li>
<li><span style="font-size: 12px">Ability to clearly communicate complex issues, observations and resolutions to management</span></li>
</ul>
<p style="text-align: justify"><span style="font-size: 12px"><b>Reasoning ability</b></span></p>
<ul>
<li><span style="font-size: 12px">Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions</span></li>
<li><span style="font-size: 12px">Work on complex problems where the analysis of situations or data requires in-depth evaluation</span></li>
<li><span style="font-size: 12px">May determine methods and procedures on new assignments</span></li>
</ul>
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|
|
Jan 19th, 2019 10:10AM
|
Jan 19th, 2019 10:10AM
|
Principia Biopharma
|
|
|
|
nasdaq:prnb
|
principiabio.bamboohr.com
|
principiabio.bamboohr.com
|
Jan 19th, 2019 12:00AM
|
Medical Writer
|
Open
|
Regulatory
|
Contractor
|
|
South San Francisco
|
California
|
USA
|
Oct 25th, 2018 12:00AM
|
|
<p><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Medical Writer</span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">This is a medical writers position that requires use of scientific knowledge and writing skills to effectively and clearly communicate. This position requires focus on scientific medical writing, which includes medical studies, drug trials and regulatory documents. </span></p>
<p><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Responsibilities: </span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Work with cross functional teams and conduct literature searches to enhance their background understanding, and evaluate and analyze the information they will be writing about.</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">It ensures that all deliverables are in accordance with regulations, standards, and guidelines. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">The regulatory documents that the Medical Writer prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Must understand the levels of evidence required to achieve regulatory, marketing and regulatory goals</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Responsible compilation, writing, and editing medical and regulatory writing covering all phases of clinical research for submission to regulatory agencies or Ethics committees (i.e. clinical study reports, create summary or changes, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data, publications, etc).</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Conduct adjudication meetings, maintain version control and insure timelines are agreed upon and met.<span> </span></span></p>
<p><b><span style="color: #181717;font-family: 'Arial',sans-serif"> </span></b><b><span style="text-decoration: underline"><span style="color: #181717;font-size: 14.0pt;font-family: 'Arial',sans-serif">Medical Writer Skills</span></span></b></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">At least 10 year of experience in pharmaceutical development or related experience</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Proficiency in Word, Excel, PowerPoint, email, and the Internet</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Extensive knowledge of English grammar with a familiarity with a standard style guide</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to communicate scientific or medical information in a clear and concise manner</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Familiarity with the principles of clinical research</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to interpret and present clinical data and other complex information</span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">A strong communicator with meticulous attention to detail solid writing and organizational skills. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Ability to work well independently or as part of a team including in high-pressure situations. </span></p>
<p><span style="color: #181717;font-family: 'Arial',sans-serif">Collaborative, ability to influence and reach compromises cross functionally to reach a quality document </span></p>
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Jan 19th, 2019 10:10AM
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Jan 19th, 2019 10:10AM
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Principia Biopharma
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