7 days old

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 Senior Director, Head of Global Regulatory Medical Writing:


 Writes or coordinates the writing and preparation of regulatory documents (eg, Module 2 and other clinical CTD documents, briefing and response documents [requests for information, deficiency letters], pediatric clinical development plans, clinical study reports, protocols).
 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 and sets direction at the therapeutic area level for medical writing of documents and complex submissions
 Works independently and collaboratively in a cross-functional global team representing medical writing on clinical development teams


Provides leadership and sets direction for the creation/revision of document templates, development of process, and creations/revision of SOPs and guidance documents
 Accountable for creating and maintaining budget for all medical writing deliverables at program or TA level
 Accountable for preparing, reviewing and maintaining document timelines at a program and therapeutic area level
 Provides oversight of assigned internal and external medical writers to deliver high-quality documents on time, consistent with internal standards, and within budget
 Provides direct management and/or mentoring for more junior medical writers
 Provides input into resourcing and outsourcing strategy and helps oversee Clinical Research Organization (CRO) alliance and other outsourcing activities
 Responsible for tracking/providing metrics and established key performance indicators,
 Identifies processes that require improvement, and leverages experience and enterprise thinking 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 in Medical writing
 Native English speaker with extensive knowledge of English grammar, including familiarity with a standard style guide
 At least 10 years writing experience of clinical regulatory documents in the Biopharmaceutical/CRO industry.
 Knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
 Ability to interpret, communicate and write scientific results in a clear and concise manner.
 Strong communications, organizational, time management, and project management skills
 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, execution and analysis
 Demonstrated Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
 Experience with direct or indirect management of other medical writing professionals
 Ability to plan, manage, and optimize resources
 Strong leadership, conflict-resolution and influencing skills
 Strong 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: 2021-05-03 Expires: 2021-06-02

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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Director, Medical Writing

Teva Pharmaceuticals
West Chester, PA 19380

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