1+ months

Sr. Submissions Specialist (CMC Dossier Development)

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!

Job Description

Teva is currently seeking a Biologics CMC Senior Submissions Specialist, Dossier Development.  This position manages CMC timelines and deliverables for electronic submissions to health authorities.

Major duties and responsibilities include:

  • Organize, prepare, and format submission ready Chemistry, Manufacturing and Controls (CMC) reports and other documents as required for eCTD submissions and other regulatory dossiers
  • Compile CMC sections of CTD filings for CMC Biologics products in clinical development
  • Assist in writing, editing, and formatting of documents including technical reports, procedures, and global regulatory submissions
  • Review submissions for clarity, accuracy, and consistency and compliance with authoring style guide and publishing standards
  • Manage timelines for regulatory submissions and work with the team to meet the timeline including coordination of responses to Health Authority requests for information and content preparation for Health Authority meetings
  • Day-to-day management of regulated documentation (electronic and paper)
  • Archive technical reports in the document repository such as SAGE and providing document repository compliance expertise
Qualifications
  • BS in a relevant technical discipline is required, MS desired
  • 5+ years of pharma/biotech industry experience with direct experience in technical writing
  • Excellent written and oral communication skills required
  • Experience with Biologics CMC Submissions (IND, BLA, MAA)
  • Direct experience with CTD section-Module 3 (Drug Substance and Drug Product)
  • Proficiency in ICH Q1-Q12, and  in Regulatory & Compliance Document Formatting Standards
  • Proficient in MS Word and Macro Templates, Documentum, and demonstrated organizational skills required
  • Demonstrated ability to work with cross-functional teams, and project management skill desired
  • Familiar with Visio and/or Microsoft Project
Function
Project Management
Sub Function
RandD
Reports To

In process of validation

Competencies
5. Functional - Key functional requirements set by hiring manager
Tevas 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.

Categories

Posted: 2019-09-02 Expires: 2019-11-01

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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Sr. Submissions Specialist (CMC Dossier Development)

Teva Pharmaceuticals
West Chester, PA 19380

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