Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)
Location: West Chester, United States, Pennsylvania, 19380
Company: Teva Pharmaceuticals
Job ID: 59604
Date: April 5, 2025
About Teva Pharmaceuticals:
Teva Pharmaceuticals is committed to making good health more affordable and accessible, reaching millions around the world to improve their lives. As the world’s leading manufacturer of generic medicines and a producer of several products on the World Health Organization’s Essential Medicines List, Teva helps over 200 million people every day. The company continues to innovate and seeks talented individuals to join them on this journey.
About This Role:
Teva is looking for a Manager in Global Regulatory Medical Writing to write and edit high-quality clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. This role also includes providing guidance, oversight, and resource management to support the efficient production of clinical research documentation.
Key Responsibilities:
Document Writing and Editing:
Lead author for clinical regulatory documents, such as protocols, clinical study reports, CTD Clinical Overview M2.5, Clinical Summaries M2.7, investigator brochures, briefing documents, and responses to regulatory authority questions.
Write and edit submission summaries and other complex documents ensuring they adhere to regulatory guidelines and editorial standards.
Leadership and Strategic Assistance:
Offer leadership and accountability in planning, document creation, and collaboration with cross-functional teams.
Lead comment resolution meetings and guide the team to resolve issues pertaining to clinical regulatory documents.
Contribute to the preparation and revision of document templates to streamline the document creation process.
Document Quality Assurance:
Ensure documents contain accurate, clear, and consistent medical/scientific messaging and are fully compliant with regulatory requirements.
Resource Management:
Manage contingent workers and vendors and provide training and support to improve efficiency and quality in document production.
Qualifications:
Education:
PhD or PharmD in Life Sciences (or a related field), or a Master’s degree in Life Sciences (or a related field).
Experience:
PhD or PharmD with at least 2 years of experience, or a Master’s degree with at least 4 years of experience.
Preferred: 2-4 years of experience in regulatory medical writing.
Proficiency in Microsoft Word and advanced software for document preparation.
Strong knowledge of government regulations, global submission guidelines, therapeutic areas, and statistical concepts.
Skills:
Expertise in writing and editing clinical regulatory documents, including complex materials like submission summaries.
Ability to manage multiple documents and deadlines effectively.
Skilled in problem-solving, strategy development, and facilitating effective communication to ensure successful outcomes.
Compensation:
Annual Salary: $111,000 - $146,000 (depending on location, skills, experience, and other qualifications).
Bonus: Eligible based on performance.
Benefits Package:
Comprehensive health insurance (medical, dental, vision, prescription).
401(k) with employer match (up to 6%) and an annual 3.75% contribution.
Paid time off, including vacation, sick, holidays, and floating holidays.
Life and disability protection.
Additional benefits like Employee Stock Purchase Plan, Tuition Assistance, and paid parental leave.
Role Location:
US-Based Remote (Eastern time zone preferred).
Note: Relocation assistance and work visa sponsorship are not available for this position.
Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals values diversity and is committed to equal employment opportunities for all candidates regardless of race, gender, disability, or other protected statuses. The company ensures that all candidates are provided with equal opportunities throughout the recruitment process, with accommodations available when needed.
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