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Director, Therapy Area Head, Medical Writing-REMOTE

Date: Jan 10, 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

As a Director your role will be in the Global Regulatory Medical Writing Group (GRMW) of the larger Biometrics organization in Teva’s Specialty R&D organization.  Reporting to the head of GRMW, the primary responsibility of this role is to provide leadership for all medical writing activities for the growing, and innovative pipeline within one of Teva’s core therapeutic areas. 

 

In some cases, this role will have oversight and be responsible for Medical Writing deliverables for one or more compounds outside the assigned TA.   In this role, you will directly manage and oversee a team of medical writers, will have accountability for all medical writing deliverables within the TA and provide leadership with respect to resourcing strategy, project management, processes and SOPs to the larger medical writing organization. 

 

You will set resourcing strategy for medical writing deliverables within the TA and contribute to setting broader medical writing resourcing strategy including outsourcing strategy. You will be tasked with creating and maintaining a budget for all medical writing deliverables with the TA and you will represent medical writing function in senior level cross-functional clinical development teams.

 

Other duties:

  • As a TA leader for medical writing, set direction and strategy for writing of documents and complex submissions across the entire TA
  • Lead or contribute to the creation/revision of document templates, development of new medical writing processes including technical enhancements, and creation/revision of SOPs and guidance documents
  • Oversee and ensure timely and quality delivery of the writing and preparation of key documents including protocols, Investigator Brochures, clinical study reports, regulatory briefing documents and Health Authority responses, and CTD submission documents
  • Provide guidance to the development team on the appropriate organization and presentation of information within documents and alignment to key messaging
  • Accountable for overall execution and/or preparation of document timelines at a program and TA level
  • Responsible for creation and tracking of metrics and established key performance indicators
  • Identify processes that require improvement, and leverage experience and industry thinking to recommend strategies and solutions
  • Participate in the recruiting/hiring and performance management processes, and professional development of direct reports including identifying learning/training opportunities and executing development plans

 

Full time remote flexibility 

Qualifications

What you will bring to the role:

  • Master's degree in Pharmacology, Biology, Chemistry or other related life science
  • Minimum 10 years of Biopharmaceutical/CRO industry experience
  • Minimum 8 years of experience writing clinical regulatory documents 

 

Preferred Qualifications:

  • PhD, PharmD
  • Knowledge of various TAs (preferably the TA to which the candidate would be assigned to), regulatory/scientific guidelines, clinical trial design and conduct, and key statistical concepts
  • Experience with an electronic document management system
  • Demonstrated Leadership role with complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
  • Experience with or demonstrated ability to successfully lead/directly manage other medical writing professionals
  • Ability to plan, manage, and optimize resources

Function

Research & Development

Sub Function

Clinical Development Medical Writing

Reports To

Head of Global Regulatory Medical Writing

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. 


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