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Senior Manager, Medical Writing - REMOTE

Date: Jun 27, 2022

Location: West Chester, Pennsylvania, US, 19380

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

R&D:
Teva’s 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
In your new position you will report to the Director, Head of Global Regulatory Writing, Medical Writing - US

  • Writes and/or edits clinical regulatory documents (all document types).
  • Create and manage yearly Development Safety Update Reports (DSURs) and NDA/BLA/IND annual report schedules. 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.
  • Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents, author and update SOP for DSURs.
  • Lead collaboration meetings with RA and PhV to discuss improvements and resolution for issues involving DSURs.
  • Ensures quality assurance of own documents - implementation of comments received from CQA.
  • Provide training for DSURs to internal stakeholders and their designated CRO.
  • Prepares or reviews and maintains document timelines
  • Uses various tools, business systems, and repositories
  • 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 from CRO; monitor costs of projects, and approve invoices for projects submitted.
     

Qualifications

Minimum Qualifications:

  • B.Sc. or a Master's degree in Life Sciences (or other related field), both with a minimum of 10 years of experience in Pharma.
  • Minimum7 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 clinical data in a clear and concise manner.
  • 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
  • Experience managing direct and indirect reports, including medical writing contractors

 
Preferred Qualifications:

  • Previous experience with writing, reviewing and performing quality assurance of NDA/BLA annual reports and IND annual reports.
  • Previous experience with creating and managing yearly Development Safety Update Reports (DSURs)
     

Function

Research & Development

Sub Function

Clinical Development

Reports To

In process of validation

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.


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