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Sr. Manager, Medical Writing

Date: Jan 14, 2022

Location: Netanya, IL, 11111

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

A Sr. Manager in the Global Regulatory Medical Writing department at Teva provides hands-on writing and/or basic-level oversight of outsourced-prepared clinical research documents for the Clinical Specialty Development organization (and other departments as appropriate). This role supports the areas of drug development and product registrations.

Essential Duties & Responsibilities:

  • Writes and/or edits clinical regulatory documents (all document types)
  • Provides contractor oversight for outsourced writing deliverables, and identifies, deploys and manages resources
  • Prepares or reviews and maintains document timelines
  • Oversees/Mentors for all document types and offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
  • Ensures that clinical documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
  • Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
  • Performs quality assurance review of documents and participates in meetings at the document team and clinical sub-team levels
  • Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
  • Uses various tools, business systems, and repositories
  • Exhibits competent collaboration, conflict-resolution, and influencing skills
  • May participate in the recruiting/hiring process

Qualifications

  • MSC/PhD degree in Life Sciences (or other related field), both with a minimum of 5 years writing experience of clinical regulatory documents in the Pharma/Biotech or CRO industry
  • Native level English [IL only]
  • Familiarity with the principles of clinical research and drug development, including clinical trial design, operations, and results analysis
  • Ability to prepare any type of regulatory document (CSR, Protocols, clinical sections for submissions)
  • 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
  • Previous experience in project management
  • Ability to work independently

Function

Research & Development

Sub Function

Clinical Development

Reports To

Sr Dir Clinical Development Medical Writing, Medical Writing - US

Already Working @TEVA?

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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.