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Senior Submission Specialist

Date: Jun 24, 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!

Teva offers a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. If you would like more information please visit us at www.tevapharm.com or www.tevausa.com


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

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!
Teva is currently seeking a Senior Submission Specialist, CMC Dossier Development reporting to the Associate Director, CMC Dossier Development.
MAJOR DUTIES AND RESPONSIBILITIES

  • Organize, prepare, and format submission ready Chemistry, Manufacturing and Controls (CMC) reports and other documents as required for eCTD submissions and other regulatory dossiers
  • Manage the preparation and review of 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 CMC submission content for clarity, accuracy, and consistency and compliance with authoring style guide and publishing standards
  • Manage timelines and deliverables for CMC regulatory submissions, 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 and provide document repository compliance expertise

Qualifications

  • BS or MS in a relevant technical discipline is required
  • Minimum of 5 years of pharma/biotech industry experience 
  • 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 Regulatory & Compliance Document Formatting Standards
  • Proficient in MS Word and Macro Templates and Documentum
  • Demonstrated organizational skills required
  • Demonstrated ability to work with cross-functional teams
  • Project management
  • Familiar with Visio and/or Microsoft Project

Function

Project Management

Reports To

Assoc Dir, CMC Dossier Development, Biologics CMC, West Chester - 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. 
We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 
Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations. 


Nearest Major Market: Philadelphia