Senior Director, Head of Global Regulatory Medical Writing- Remote

Who are we?

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 Senior Director in Global Regulatory Medical Writing provides leadership, direction, and competence to a team of medical writers/managers and electronic document specialists within Clinical Development for the production of high-quality clinical research documentation, which adheres to departmental standards and regulatory guidelines, in support of drug development, product registrations, and product marketing to meet the company’s global strategic, scientific, regulatory, and commercial goals. The Senior Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.  This role serves as a liaison among internal/global functional groups to ensure optimal use of resources in making medical writing support available for all projects. The Senior Director provides mentoring and proficiency to manager-level direct reports.

 

Qualifications and Skills:

• Masters in Life Sciences (or related field) with a minimum of 10 years of relevant medical writing experience or PhD (preferred) in life sciences (or other related field) with a minimum of 5 years of experience related to medical writing. 
• Highly skilled at setting regulatory medical writing processes/policies and technical and editorial standards; leads initiatives to improve medical writing processes and standards
• Leadership skills and presentation skills to influence, negotiate, and collaborate with teams for any medical writing process and template initiatives.
• Considered an internal expert in all aspects of regulatory medical writing; demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines. Knowledge of regulatory guidance and industry standards.
• Able to provide a clear vision and strong leadership to the medical writing team
• Issue resolution skills, being able to manage cross-functional teams through complex processes given clear direction
• Represents medical writing in cross-functional teams
• Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
• Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
• May participate in orientation and coaching of junior managers or contractor writers
• Able to represent Medical Writing in industry standards working groups

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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.

 

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