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Senior Medical Writer

Date: May 23, 2021

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

A Manager in the Global Regulatory Medical Writing and Submission Management organization at Teva provides basic-level oversight and guidance, as well as resource management, for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation. This role supports the areas of drug development, product registrations, and product marketing. International and domestic travel required and ample opportunity for professional growth!

Essential Duties & Responsibilities:

  • 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 these 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
  • Provides mentoring and know-how to medical writers preparing any document type
  • 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
  • Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
  • Provides contractor oversight and Identifies, deploys and manages resources
  • Exhibits competent collaboration, conflict-resolution, and influencing skills
  • Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans

Qualifications

  • MSc/PhD in life sciences (or other related field) with a minimum of 3 years of writing experience in medical writing and or/regulatory writing
  • Native level English
  • Previous experience with writing regulatory documents in medical device and Pharma
  • Experience in preparation of regulated documents in the pharmaceutical/biotech/medical device industry.
  • Ability to prepare any type of regulatory document(CSR, Protocols, clinical sections for submissions)
  • Detailed oriented
  • Previous experience in project management
  • Ability to work independently
  • Ability to manage without authority

Function

Research & Development

Sub Function

Clinical Development Medical Writing

Reports To

Director, Head of Global Regulatory 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.