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PAREXEL

- NASDAQ:PRXL
Last Updated 2019-07-19

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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Senior Project Quality & Risk Lead Open Parexel Harrow Middlesex GBR Jun 4th, 2019 12:00AM Senior Project Quality & Risk Lead acts as primary project quality expert, point of contact and support to project team leadership throughout the project. Manage the Quality Evaluation (QE) workflow. Communicate results to the project team (PL, FLs). Provide support with quality issue management, audits and inspections, and project quality and risk consultancy as required. Assess operational execution using a risk-based approach to verify adherence to standards and assist with remediation when required. Facilitate quality related interactions with clients. Mentor Project Quality & Risk Lead, as assigned.

Key Accountabilities:

 Perform, report, and coordinate the quality evaluations for assigned projects
o Verify compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements
o Actively participate in key internal project team meetings and facilitate quality discussions during these meetings
o Schedule and lead the project related Quality Forums
o Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality
o Provide quality advice to the project teams and participate in relevant project team training
o Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, assist in determination of root cause and consultation on appropriateness of corrective and preventive actions
o Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs

 Represent Quality Management in audits and inspections as required.
 Mentor Project Quality & Risk Leads, as assigned
o Fulfill the mentor role for Project Quality & Risk Leads, as assigned
o Provide consultancy and guidance to Project Quality & Risk Leads, as assigned
 Build and maintain relationships with clients / act as primary point of contact for communications with client quality representatives
 Fulfill role of Portfolio Quality Lead, as assigned
 Serve as quality consultant for assigned accounts to senior project leadership personnel and assist with the oversight of quality aspects of the client program
o Review key portfolio documentation from a quality standpoint
o Provide support and consultancy for portfolio quality issue
o Facilitate portfolio level compliance with the Corrective and Preventive Actions (CAPA)
o Coordinate Project Quality & Risk Leads assigned to the client as needed
o Provide audit and inspection support for portfolio, including, where feasible, advising the project teams during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on portfolio related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as assigned.
o Oversee the collection and reporting of portfolio quality metrics. Evaluate the quality status of a portfolio by reviewing applicable quality metrics.
 Identify process improvement opportunities
o Oversee the collection
o Report process gaps and participate in implementation of process improvement when required



Qualifications

Skills:
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• Substantial clinical trials experience
• Leadership and/or project management skills
• Ability to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs)
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Ability to travel approximately 30% - 50%.

Knowledge and Experience:
• Relevant experience (e.g., in the pharmaceutical or CRO industry).
• English proficiency (written and oral English)

Education:
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Application Support Analyst Open Parexel Nottingham Nottinghamshire GBR Jun 6th, 2019 12:00AM PAREXEL Informatics is one of the industry’s leading solution providers and we help customers accelerate the drug development process through innovation. Our product portfolio is built on leading-edge technology and is combined with extensive medical and clinical expertise. As the technology business unit of PAREXEL International Corporation, we're able to leverage our massive investment in technology with our parent company's wealth of hands-on clinical expertise.

This role is based in our new modern state of the art office in Nottingham city centre which has excellent transport links and has a great working environment that has the feel of an innovative technology company.

Job Purpose:

Application Support Analyst primary role is to provide excellent customer service whilst resolving technical incidents or requests raised by end users of PAREXEL supported systems or PAREXEL applications.

Key Accountabilities:
  • Providing excellent Customer Service via the telephone and email system
  • Logging Incidents and/or requests in the IT Service Management tool

  • Provide user support, coaching/mentoring end-users in the working of the PAREXEL client facing systems
  • Maintain rapport with Customers by displaying a detailed understanding of their support requirements
  • Maintain high levels of incident ownership through the incident lifecycle to a satisfactory Customer resolution
  • Proactively manage updates to all parties with Incident/Requests statuses through to resolution
  • Develop and maintain communication skills appropriate to the environment
  • Understand and proactively operate the escalations procedure
  • Consistently meet Service Desk (KPI) Key Performance Indicators as set by the Service Manager
  • Follow Service Desk / Operations internal processes regarding logging incidents and following the defined incident management process.
  • Provide shift cover within current Service Desk operations.

Qualifications

Key Skills
  • SQL and PL-SQL
  • Any ETL experience is beneficial
  • Basic understanding of the XML technologies such as (XML Schema, XSL conversion)
  • Basic Understanding of JAVA
  • Ability to work in IT service management (ITSM) environment such ITIL framework
  • Basic Understanding over the integration platforms and methodology to exchange data
  • Assertive, confident, positive and professional manner
  • Ability to deal with potentially stressful situations
  • Flexible and adaptable as the business demands
  • Excellent problem solving skills
  • Strong attention to detail in logging support calls, updating call details and managing call closure
  • Ability to work under pressure
  • Strong eye for detail
  • Able to follow a strong approach to task and issue management, including documentation
  • Ability to build strong and collaborative relations with clients through various methods
  • Able to maintain a strong and proactive approach to information and knowledge acquisition
  • Ability to clearly and effectively convey information via a variety of different methods targeted to varying audiences to yield maximum effect and benefit
Data Analysis: Be able to understand how to use simple data analysis, data modelling and quality assurance techniques, based upon a detailed understanding of business processes. Based upon application knowledge a Technical Support Analyst will be confident in suggesting work arounds to resolve incidents.

Database: Awareness of database concepts; querying multi-level applications; object and data modelling techniques and design desirable.; Ability to evaluate potential solutions by demonstrating a broad knowledge of how data flows through a given platform.

Customer and Client Service: Deliver a positive, memorable and meaningful service exceeding the expectations of both internal and external customers. Ensure that all incidents and requests are fully documented: ensure sufficient detail received by end user to aid resolution and be ready and able to contribute towards building and maintaining knowledge management systems.

Experience:
  • Degree in Computer Science or equivalent essential
  • Ability to read code and understand
  • Customer Service experience essential
  • Understanding of SQL essential
  • Technical Helpdesk experience desirable
  • ITIL Incident and Problem management desirable

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary and benefits package including 25 days holiday per year, pension scheme, life assurance, long term disability insurance, a health cash plan and other leading edge benefits that you would expect with a company of this type.

Apply now to begin your journey!
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Senior Scientific Specialist Open Parexel Home Based Any Region GBR Jun 7th, 2019 12:00AM Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

This role can be based at either our UK Head Office in Uxbridge or at our new Littlehampton office and depending on your level of experience it could be home based. The Uxbridge office is close to both Uxbridge train station as well as the town centre and the building has plenty of free onsite parking . Our office in Littlehampton is in a great location.

As the Senior / Scientific Specialist you would be part of our Scientific and Editorial Services department. You would act as senior therapy area/content expert and lead the delivery of assigned programs/projects within the account team interacting directly with clients. You would also develop high-quality scientific content by all means of necessary research, scientific writing, editing and fact checking to meet deadlines while working within the project scope and objectives. This would apply to all formats of MedCom’s communication outputs.

In the role you would also acquire and maintain expert knowledge of relevant therapy areas, client products, and objectives as well as taking ownership of assigned projects and programs and take independent action to resolve complex technical issues to ensure excellent project delivery. You will work in partnership with the Scientific Team Lead to ensure quality delivery, client satisfaction, and account growth.

As the Senior / Scientific Specialist you will liaise effectively with client and external authors/opinion leaders during the lifecycle of assigned projects or programs and work directly on projects or provide expert guidance of projects/programs being undertaken by other team members.

Key Accountabilities:

Client Interaction/Relationship:
- Act as senior content expert on assigned accounts/programs and proactively build client relationships and, in conjunction with Scientific Team Lead and Account Management, ensure client satisfaction and project profitability
- Identify complex technical and process challenges, and work in partnership with Scientific Team Lead to resolve problems/challenges
- Be alert to opportunities to develop follow-on business, and, as a content expert, develop and endeavor to secure NBAs in conjunction with Account Management.

Specialized Knowledge
- Demonstrate sufficient understanding of department’s service offerings in order to:
o Ensure that discussions with client are informed, appropriate, and consistent with MedCom’s service offerings
o Contribute to client solutions
o Discuss opportunities or issues with account team leadership
- Be familiar and comply with all departmental procedures related to project delivery and tracking, promote adoption of these procedures by others, and recommend appropriate enhancements for efficiency.

Project Execution and Success
- Undertake writing and editing to develop high-quality scientific content
- Prioritize own work and manage project schedule to meet delivery deadlines
- Be familiar with and work within project scope (specification and budget hours) and objectives. Monitor project progress, scope changes, and own hours sufficiently to flag changes in scope to project lead, and proceed accordingly Interpret scientific data accurately and appropriately.

Qualifications

Skills
- Experience of Oncology is essential.
- Advanced computer and Internet skills, including knowledge of MS applications such as Word, PowerPoint, and Excel
- Advanced oral and written communication skills
- Advanced problem-solving skills
- Technical expertise:
o Ability to acquire and apply specialized therapy area knowledge rapidly
o Good breadth of therapy area knowledge
o Ability to interpret and organize highly complex scientific data
o Ability to understand and implement marketing messages
o Scientific writing competency
o Proofreading and copyediting skills
o Ability to quality control check own output according to editorial SOPs, and review and QC work from other team members-
- Effective project management skills
- Effective interpersonal skills and relationship-building competency
- Ability to lead projects and programs
- Strong client focus
- Ability to interact professionally within a client organization
- Ability to prioritize work and define steps needed to achieve specified project outcomes
- Ability to successfully manage assignments on time with high quality
- Strong presentation skills
- Strong mentoring skills
- Willingness to undertake continuous professional learning and development
- Willingness to work in a matrix environment and to value the importance of teamwork

Education
- Degree and a higher degree in Life Sciences, Pharmacy, or Medicine is essential (BSc, BA, preferred. PharmD, PhD, MD are desirable).

Language Skills
- Proficient use of English language

Minimum Work Experience
- Strong prior experience in a similar role within a medical communications agency environment or pharma company.
- Ideally would have good levels of independent responsibility and accountability working as a Medical Writer with strong Oncology experience.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus incentive scheme, company car / car allowance plus a good benefits package including 25 days holiday per year, pension scheme, life assurance, long term disability insurance, a health cash plan and other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your
Parexel journey!

Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Director, CCMEE & Digital Media Open Parexel Littlehampton West Sussex GBR Jun 7th, 2019 12:00AM Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

This role will be based in our new modern office situated in Littlehampton. It will also cater for 1-2 days working from home if required.

As the Director of Creative Clinical Communications, Meetings, Events & Editorial , you will be accountable for the successful service line delivery and long-term growth of the Clinical Communications group, Global Studio Services and Digital Media. You will provide strategic, operational and functional leadership, management and direction to these groups and be responsible for developing new business strategies and innovative solutions for our clients.

Accountability:

Strategic Leadership
- Develops functional operational strategy, establishes vision and proactively and regularly communicates within the group and organization
- Acts as cross- department advocate for change on operational issues
- Aligns strategic initiatives with MedCom’s vision and strategy
- Ensures departmental initiatives are aligned with strategy
- Comprehensive understanding of MedCom’s service offerings as well as SBU and networks across Parexel.

Operational Leadership
- Leadership, direction and management of the Clinical Communications group, Global Studio Services and Digital Media team to ensure client focused, profitable and timely delivery of all projects and programs to the highest standards
- Identifies industry best practices & tools, and drive a culture of business development, efficiency and continuous improvement
- Address operational and client issues that are beyond the scope of the Manager
- Works closely with the VP and colleague managers to exploit future opportunities within client accounts for Meetings, Creative, Clinical Communications and Digital Media

Team Leadership
- Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
- Ensures appropriate resources and skills are in place to deliver against business objectives for the group
- Participate in formal staff review processes

Financial Oversight
- Works with the VP to establish and ensure achievement of annual departmental P&Ls & develop financial metrics and ongoing forecasts for operational activities
- Ongoing management and oversight of the group’s financial metrics to achieve P&L targets in conjunction with Finance Business Partner and Finance team

Business Development:
- Actively prospect and leverage potential business opportunities within specified account(s) and across MedCom
- Develop detailed business plans and sales strategies for each account in liaison with VP
- Maintain good understanding of the breadth of MedCom capabilities in order to ensure appropriate strategy/solution is proposed to client
- Work closely with respective account management teams and Customer Strategy team on new business opportunities
- Lead and champion the entire sales process: take client brief, identify appropriate team; brainstorm creative solutions; prepare the proposal and pitch presentation; lead the discussions with client and confirm the business
- Respond to RFPs and lead the proposal development process (and team) in the creation of the proposal

Qualifications

Education
- Degree in a relevant area to include Marketing, Business Management or Communications and/or equivalent managerial, business development and account management experience as above within the pharmaceutical industry in a similar role is required

Language Skills
- Clear English communication skills in all written and verbal formats.

Skills:
- Strategic thinking and implementation
- Proven management experience including conflict resolution
- Demonstrates strong leadership capabilities
- Ability to manage a team
- Change management
- Solution-focused
- Motivational leader
- Strong customer focus
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Advanced problem-solving skills
- Creative, resourceful and proactive
- Excellent interpersonal, verbal and written communications
- Sound understanding of IT packages such as Word, Excel, PowerPoint and other business applications
- Ability to work under pressure and meet several concurrent deadlines

Knowledge and Experience:
- Strong and advanced level experience in a Line Management position (Director) across a team of at least 5+ employees working ideally across different functions.
- Worked at a minimum level of Manager , preferably more Senior Manager or Director.
- Worked in a large Corporate environment is desirable.
- Previous CRO, Pharmaceutical Industry, Client or MedComs Agency experience is essential
- Previous experience in patient and Investigator communications supported by innovative technology solutions is ideal
- Extensive knowledge of the digital landscape in healthcare to include technical knowledge and its future state is desirable.
- Technical expertise of Studio deliverables to include page layout and print preferably in a MAC environment is desirable.
- Able to demonstrate proven success in account management and client relationship building and leveraging new business opportunities to develop new service offerings.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary, bonus, company car or car allowance as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!

Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Project Coordinator Open Parexel Littlehampton West Sussex GBR Jun 10th, 2019 12:00AM

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role will be based at our new Medical Communications office situated in Littlehampton, we are a close distance to the train station as well as the town center and we have the feel of an innovative and collaborative medial communications agency.

You will be working as part of our successful Scientific Services and Account Management group and report into one of the Account Directors and be part of their collaborative team.

As the Program Coordinator you will provide highly skilled, proactive project coordination and support to an assigned account team and for allocated projects to ensure efficient and effective management of projects within agreed priorities and time scales to the highest quality, in line with budget, and with minimal supervision

Your responsibilities will include internal project tracking, liaising with client and faculty on project set up and progression, maintaining internal/client databases and documents as well as maintaining financial documentation, support the team in proposal, budget and pitch development.

Key Accountabilities:

Support Account Team for Successful Project Delivery
- Provide team members with skilled support in the implementation and management of specified projects within agreed time schedules and budgets
- Proactively maintain and circulate project tracking and status reports, internally (including liaison with the studio) and externally
- Set up and maintain accurate project information on all tracking tools (internal and external)
- Assist with QC and fact-checking on requested projects
- Responsible for preparing for team meetings, including scheduling, material preparation, creation and maintenance of project tracking materials, timeline creation, taking minutes, and addressing any other issues; attend internal client/project meetings as appropriate
- Responsible for the maintenance of client publication tracking tools, eg, Datavision, PubStrat, both content and financial
- Assist with the financial tracking of projects, including preparing hour reports, invoice schedules, client financial project tracking reports.

General Team Support
- Proactively set up and coordinate with Manager the Induction Program for new starters
- Actively contribute to induction programs and the training and development of new support staff and other employees
- Organize all travel and accommodation for team members
- Make all necessary arrangements for client visits and off-site meetings
- Handle all incoming and outgoing project-related mail appropriately and promptly; carry out routine checking of e-mail in absence of team members, pass on to relevant employees or action as appropriate
- Adhere to company courier and postal procedures
- Maintain relevant internal and external e-mail distribution groups
- Archive completed projects (electronic and hard copy) on a regular basis, in accordance with the company archiving policy

Qualifications

Education
- Ideally Degree preferred, eg, Life science, Marketing, Business qualifications but not essential.

Language Skills
- Proficient use of the English language in both written & verbal format

Skills
- Competent in the use of Word (Advanced), PowerPoint (Advanced), Excel (Advanced), Outlook (Advanced) and Reference Manager (Intermediate) and sound knowledge of databases (eg, Access)
- Ability to source information using the Internet and other media
- Confident processing financial information and trackers under the guidance of Manager
- A confident self-starter who is capable of knowing how best to action/respond to specific requests and information received from a variety of external and internal sources
- Strong interpersonal and communications skills, including ability to compose own correspondence to agree professional standard
- Excellent organizational and multi-tasking skills, with the ability to coordinate several projects at different stages, meeting strict deadlines and follow-up proactively; effective time management
- Accuracy and attention to detail
- Team player with client-focused approach
- Motivated, proactive, flexible approach, with ability to follow tasks to completion
- Exhibit confidentiality regarding sensitive information and a professional demeanor at all times

Minimum Work Experience
- Previous project, program or team coordination experience is ideally preferred from a medical communications agency background or similar working environment.
- Experience within the medical communications environment would be an advantage.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Solutions Consultant, Director or Senior Director – Access Open Parexel Home Based Any Region GBR Jun 11th, 2019 12:00AM

The Solutions Consultant will be a recognized professional in her/his area (technical, functional or therapeutic), with experience in the design, operational conduct and successful delivery of Solutions globally. S/he works in partnership with Enterprise Accounts, Growth Accounts, Commercial Operations and SBUs to optimize new business awards through the development of compelling operational and technical strategies and business solutions to support current and future client needs. These strategies will include in-depth risk assessments and scenario plans.
Key Accountabilities:-
* Sales Support
* Solutions Development (Therapeutic, SBU, Technical)
* Solution Communication
* Solution Adoption and Delivery

Qualifications

Successful candidates will have:

A degree in a science or health related field, (advanced degree preferred) or equal work experience
A minimum of 10 -15 years clinical research experience preferred with at least 7 years Project/Program/Portfolio Management experience of domestic and international studies across all phases, but including extensive Phase III-IV study work.
A strong background in Late Phase (IV) work is preferred.


Candidates should have a proven record of team building and leadership skills, strong client interaction, conflict resolution and risk management, plus a strong financial knowledge. This position will also require heavy prior interaction working with Business Development developing and maintaining client relationships, winning new business and participating in the proposal and bid defense process. Prior CRO experience is preferred.

Minimum Work Experience
• Significant Pharmaceutical Industry Experience
• Clinical Research and/or Product Marketing
• Business Development/Consultancy
• Budget Management
• Line Management
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Technical Vice President, Parexel Consulting (Compliance) Open Parexel Home Based Any Region GBR Jun 11th, 2019 12:00AM Also Considering Applicants in Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden &Switzerland.

Seeking a CMC Biologics SME to join PAREXEL’s highly recognized Team!


Are you dedicated to Public Health? Committed to making a difference? But you feel like you’ve hit a ceiling professionally and you’re unsure of the next step in your career… Well, PAREXEL Consulting is growing and we're seeking experienced Regulatory professionals just like you, who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients.

PAREXEL’s Consulting team is known for our unparalleled breadth and depth of expertise globally. PAREXEL Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

We currently have a home-based/office-based opening on Team for an Industry Thought Leader to join PAREXEL's Consulting Team of experts as a Vice President, Technical (CMC Biologics).

A Technical VP must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as, extensive knowledge of what services PC provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other PC employees and leads knowledge-centered activities within PC. A Technical VP participates in the development of new service offerings, consulting models and methodologies.

Project Execution

  • Works within a team environment or individually based on the project needs
  • Works within broad project guidelines and leads issue and conflict resolutions
  • Prioritizes own work load and prioritizes the work load of the project team to achieve the project scope and objectives
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
  • Manages project engagements (small or large)
  • Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
  • Provides guidance to project team members and acts as a mentor to junior staff
Thought Leadership
  • Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field
  • Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
  • Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of PC are met
  • Regularly quoted by general and industry news outlets
  • When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations
  • Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
  • Reinforces the knowledge-centered activities within PC based on their own knowledge and expertise
  • Facilitates improvements to the PAREXEL business processes
  • Facilitates new service and consulting model development

Qualifications

Consulting Activities and Relationship Management
  • Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs//improves the methodologies when needed
  • Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
  • Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
  • Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined
  • Acts as a loaned executive for a client when required
  • Facilitates resolutions to possible problems or conflicts within the project team and/or the client
  • Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
  • Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers
  • Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite
  • Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals
  • Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management

Requirements
  • Minimum of an advanced degree in a scientific or technical discipline or MBA, PhD preferred, or equivalent experience
  • Pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, etc also desirable but not mandatory
  • Numerous years experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA)
Now is the time to join this DYNAMIC Team and work alongside like-minded colleagues with a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Senior Director / Vice President, Biostatistics Open Parexel Home Based Any Region GBR Jun 11th, 2019 12:00AM Also considering Applicants from Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden and Switzerland.

Purpose of the job:

The Biostatistics Senior Director / Vice President is responsible for statistical consulting, strategic advice and operational execution in drug/device /diagnostic developments up to submissions and approvals as well as successful reimbursement applications. The Biostatistics Senior Director serves as an executive sponsor for enterprise and growth accounts promoting client engagement (need to reword this better). The Biostatistics Senior Director / Vice President leads and contributes to strategic initiatives and working groups within GDO and Biostatistics and Statistical Programming to build a world-class group of Biostatistics experts. S/he is responsible to actively promote new business by participating in project bids and client presentations as appropriate. S/he works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business. The Biostatistics Senior Director is an experienced leader responsible for liaising with senior levels of management within the organization and to deputize for the Vice President or Corporate Vice President as needed.

Key Accountabilities:

•Offer world-class Biostatistics consulting and operational execution
•Provide consulting and guidance throughout the clinical development process
•Provide statistical expertise in designing clinical development programs, individual protocols, optimizing existing protocols, preparing submissions
•Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client
•Support interventional and non-interventional studies
•Review and participate in writing publications
•Act as executive oversight of a large project where applicable

Business Development:

•As a world-class expert in Biostatistics and Statistical Programming attract new business for PAREXEL
•Work closely with Business Development, Medical, Solutions Consultants and other PAREXEL functions and attend client meetings as a subject matter expert in Biostatistics
•Contribute to business development, e.g., by actively contributing to proposal development (in particular if complex statistical designs or analyses are part of the proposal), attending and preparing bid defense meetings for potential studies, programs of work and functional service providers.
•Represent PAREXEL at client marketing and technical meetings as needed
•Participate in and contribute to project bids, including client presentations.
•Provide on-going support to Portfolio Management,
Business Development, and Business Operations groups
•Support efforts for generating business leads (client networking, public speaking, etc)

Client Engagement and Other Activities:

•Serve as Executive Sponsor for Biostatistics and Statistical Programming for Enterprise and Growth Accounts
•Attend client governance meetings as appropriate
•May be responsible to coordinate client or account activities for department or function
•Participate in committees, task force groups as needed
•Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and PAREXEL
•Work with senior departmental management in developing managers and ensuring a talented pipeline of management staff within the department or function
•Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL SOPs
•Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary

Qualifications

Skills:
•Excellent organizational, communication, negotiation, problem-solving, analytical and consulting skills
•Technical leadership and contribute to a high performing team
•Expertise in optimizing trial design, development programs, submission strategies and regulatory interactions
•Outstanding understanding of the drug, device or diagnostic development process
•Expertize in broad different therapeutic areas and indications
•Thorough understanding of various statistical models and applications
•Excellent understanding of statistical issues in clinical trials and strategies to avoid them
•Thorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processes
•Thorough understanding of e-submissions, eCTD, etc
•Thorough understanding of ICH guidelines
•Excellent knowledge of all statistical and reporting processes within the Biostatistics department.
•Strategic awareness of our business environment
•Knowledge of the International pharmaceutical market and the services required by sales, marketing and operational support to achieve product success
•An ability to assess situations and make and carry through difficult decisions
•Advanced ability to successfully manage a full workload across multiple-projects
•Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
•Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer
•Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
•Advanced ability to work in a matrix environment and to value the importance of teamwork
•Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook

Knowledge and Experience:

•Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
•Direct experience in consulting
•Proven record and experience with development, execution and implementation of research strategies in the pharmaceutical industry
•Experience in designing and executing drug, device or diagnostic development programs
•Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies
•Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation
•Experience with conference presentation and manuscript writing

Education:
•PhD in Statistics or related discipline, MS in Statistics or related discipline
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Technical Vice President, Parexel Consulting (CMC Biologics) Open Parexel Home Based Any Region GBR Jun 11th, 2019 12:00AM Seeking a CMC Biologics SME to join PAREXEL’s highly recognized Team!

Are you dedicated to Public Health? Committed to making a difference? But you feel like you’ve hit a ceiling professionally and you’re unsure of the next step in your career… Well, PAREXEL Consulting is growing and we're seeking experienced Regulatory professionals just like you, who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients.

PAREXEL’s Consulting team is known for our unparalleled breadth and depth of expertise globally. PAREXEL Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

We currently have a home-based/office-based opening on Team for an Industry Thought Leader to join PAREXEL's Consulting Team of experts as a Vice President, Technical (CMC Biologics).

A Technical VP must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as, extensive knowledge of what services PC provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other PC employees and leads knowledge-centered activities within PC. A Technical VP participates in the development of new service offerings, consulting models and methodologies.

Project Execution

•Works within a team environment or individually based on the project needs
•Works within broad project guidelines and leads issue and conflict resolutions
•Prioritizes own work load and prioritizes the work load of the project team to achieve the project scope and objectives
•Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
•Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
•Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
•Manages project engagements (small or large)
•Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
•Provides guidance to project team members and acts as a mentor to junior staff


Thought Leadership

•Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field
•Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
•Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of PC are met
•Regularly quoted by general and industry news outlets
•When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations
•Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
•Reinforces the knowledge-centered activities within PC based on their own knowledge and expertise
•Facilitates improvements to the PAREXEL business processes
•Facilitates new service and consulting model development


Qualifications

Consulting Activities and Relationship Management

•Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs//improves the methodologies when needed
•Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
•Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
•Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined
•Acts as a loaned executive for a client when required
•Facilitates resolutions to possible problems or conflicts within the project team and/or the client
•Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
•Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers
•Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite
•Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals
•Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management


Requirements

•Minimum of an advanced degree in a scientific or technical discipline or MBA, PhD preferred, or equivalent experience
•Pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, etc also desirable but not mandatory
•Numerous years experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA)

Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services
nasdaq:prxl jobs.parexel.com jobs.parexel.com Jun 13th, 2019 12:00AM Director Alliance Leadership PAREXEL INFORMATICS - EUROPE Open Parexel Home Based Any Region GBR Jun 11th, 2019 12:00AM The Alliance Leadership Director (AL) is responsible for the overall health of key client relationships, including sales growth, client satisfaction, profitability and ensure PI operational teams are delivering to client expectations. Account assignment are made by the commercial leadership team. The AL works with functional teams to set the account specific strategy, accountable for its implementation and periodic reporting. Key responsibilities include; Commercial Leadership and Account Leadership.

Commercial Leadership

• Pursue new business to meet and exceed NBA targets and building long term client relationships to maintain preferred supplier status
• Understand the clients’ development and commercial strategy, product development portfolio, and pain points
• Develop a strong understanding of clients’ organizational structures and relationships with key stakeholders
• Identify client needs and develop creative solutions for projects, leveraging expertise, operational capabilities and technologies
• Maintain high visibility within client organization (e.g., therapeutic area, service line, region)
• Maintain solid knowledge of all PAREXEL services and value propositions for appropriate cross-selling opportunities
• Maintain positive client relationships to drive repeat business
• Formulation of an effective account strategy and it’s implementation.
• Direct responsibility for assigned Accounts including NBA growth, Bid pursuit, commercial negotiation of contracts
• Working in a consultative manner, identify opportunities and collaborate with functions and Solutions Consultants to develop winning and integrative solutions across within and across technology verticals
• Develop proposal narratives and executive summaries
• Lead bid pursuit meeting
• Lead and sign off proposal and pricing strategy in collaboration with cross functional colleagues, ensuring our ability to win the business, meet financial targets, risk management and profitability targets
• Ensures appropriate hand-off to delivery team liaising with Project
• Be the senior point of escalation for delivery/operational issues and arrange for follow through of resolutions via the appropriate departments
• Maintain close relationships with delivery teams for identification of new opportunities to ensure account growth

Qualifications

Knowledge and Experience

• 10 + years previous experience working in Clinical services or eClinical technology company, preferably in a CRO, Life Sciences Company or Consulting background specializing in Life Sciences.
• Experience in both sales and delivery roles
• Experience in Clinical Development

Skills

• Strategic and/or consulting skills in helping clients maximize short- and long-term drug development goals
• Ability to build relationships and to communicate at senior management level
• Solid understanding of the principles of drug discovery and development
• Demonstrated commercial acumen
• Ability to influence and maintain effective working relationships with coworkers, managers, clients and customers
• Experience in presenting, packaging and proposing integrated solutions to demonstrate value and potential return on investment to clients
• Demonstrates an entrepreneurial drive blending urgency, strategic thinking, and an awareness of influencing behavior in a global environment
• Highly effective communicator at all levels with both clients and internally. Must be open and direct with strong oral and written communication skills
• Must be comfortable operating in a demanding, fast paced environment and be capable of reacting swiftly to changing business demands
• Should be driven to deliver quality results on time and in a highly ethical and professional manner

Education - BS degree required. Advanced degree preferred.

30% + Travel
Jun 13th, 2019 12:39PM Jun 13th, 2019 12:39PM Health Care Health Care Equipment & Services

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