1+ months

Associate Director, Medical Writing

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

R&D:
Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

 

Job Description

Your new position will report to the Director, Head of Global Regulatory Writing, Medical Writing


 Writes and/or edits clinical regulatory documents (all document types).
 Prepares regulatory documents (eg, Module 2 and other clinical CTD documents, briefing and response documents [requests for information, deficiency letters], pediatric clinical development plans). Ensures documents are accurate, complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
 Guides clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
 Provides leadership/strategy at the therapeutic area  level for documents and complex submissions
 Contributes at the program, submission team, and therapeutic area level.
 Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
 Ensures quality assurance of own documents - implementation of comments received from CQA.
 Works independently and collaboratively in a cross-functional global team
 Communicates information clearly and concisely
 Manages preparation of clinical documents for submissions
 Participates in CDTs and study team meetings, provides alignment with documents within overall program strategy
 Lead CRMs and sets up document reviews as needed (eg, if MW doesnt have access to Teva systems or have a Teva systems superuser)
 Prepares or reviews and maintains document timelines
 Uses various tools, business systems, and repositories
 Provides oversight of assigned internal and external medical writers to deliver high-quality documents on time, consistent with internal standards, and within budget
 Oversees/mentors for all document types
 Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
 Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process, and handling invoices
 Identifies processes that require improvement, and demonstrates big picture perspective, leveraging experience, to recommend strategies and solutions
 Contributes to manuscript preparation as needed
 

Qualifications

Minimum Qualifications:
 Ph.D. or a Master's degree in Life Sciences (or other related field), both with a minimum of 10 years of experience.


 Native English speaker with extensive knowledge of English grammar, including familiarity with a standard style guide
 At least 7 years writing experience of clinical regulatory documents in the Biopharmaceutical/CRO industry.
 Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
 Ability to interpret, communicate and write scientific and clinical data in a clear and concise manner.
 Strong communications, organizational, time management, and project management skills are required.
 Proficient in MS Word and experience with document templates
 Experience with an electronic document management system
 Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
 Familiarity with the principles of clinical research and drug development, including clinical trial design, operations, and results analysis
 Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
 Experience managing direct and indirect reports, including medical writing contractors
 Ability to plan, manage, and optimize resources
 Strong leadership, conflict-resolution and influencing skills
 Attention to detail
 Works successfully with little direct supervision

 

Preferred Qualifications:
 Working knowledge of clinicaltrials.gov and clinicaltrialsregister.eu databases
 Proficiency in conducting literature searches and working knowledge of relevant databases

Function

Research & Development

Sub Function

Clinical Development Medical Writing

Reports To

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

 

We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 

Categories

Posted: 2021-03-29 Expires: 2021-05-20

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director, Medical Writing

Teva Pharmaceuticals
West Chester, PA 19380

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