Loading...
 
Share this Job

Associate Director, Medical Writing

Date: Jan 14, 2022

Location: Netanya, IL, 1111

Company: Teva Pharmaceuticals

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!

Job Description

  • 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 doesn't 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., PharmD or a Master's degree in Life Sciences (or other related field), both with a minimum of 10 years of experience.
  • Minimum of 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.
  • Proficient in MS Word and experience with document templates
  • Experience with an electronic document management system
  • 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

Function

Research & Development

Sub Function

Clinical Development Medical Writing

Reports To

Sr Dir Clinical Development Medical Writing, Medical Writing - US

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’s Equal Employment Opportunity Commitment

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.