Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)
Date: April 5, 2025
Location: West Chester, Pennsylvania, United States, 19380
Company: Teva Pharmaceuticals
Job ID: 59604
Who We Are:
At Teva Pharmaceuticals, we are committed to making good health more affordable and accessible, helping millions worldwide live healthier lives. Operating across nearly 60 countries with a diverse workforce, we are the world’s leading manufacturer of generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List. Every day, approximately 200 million people take one of our medicines. We are continuously seeking new ways to make a difference — and new people to join our mission.
The Opportunity:
We are seeking a Manager, Global Regulatory Medical Writing to author and edit high-quality clinical regulatory documents, including submission summaries and other essential materials critical for drug development and product registrations. This role includes providing guidance, basic oversight, and resource management to ensure efficient and seamless production of clinical research documentation.
Position Type: Full-Time, Remote (East Coast USA preferred)
How You’ll Spend Your Day:
Clinical Regulatory Writing:
Author and edit clinical regulatory documents such as:
Protocols
Clinical Study Reports
CTD Clinical Overview (Module 2.5)
Clinical Summaries (Modules 2.7.1, 2.7.2, 2.7.3, 2.7.4)
Integrated Summaries of Safety (ISS) / Integrated Summaries of Efficacy (ISE)
Investigator Brochures
Briefing Documents
Responses to Regulatory Authority Questions
Leadership and Strategic Support:
Act independently with minimal supervision.
Apply statistical and regulatory concepts when writing.
Lead multiple projects simultaneously as the principal writer.
Provide strategic support and leadership for clinical regulatory documentation efforts.
Collaborate cross-functionally to ensure production of high-quality documents within timelines.
Lead comment resolution meetings to guide teams toward successful resolution.
Process and Quality Management:
Contribute to the preparation and revision of document templates for enhanced efficiency.
Ensure accurate, clear, and consistent messaging aligned with regulatory requirements.
Manage contingent workers and/or vendors as necessary, offering training and resource oversight.
Your Experience and Qualifications:
Education: PhD or PharmD in Life Sciences (or related field), or Master’s degree in Life Sciences (or related field).
Experience:
PhD/PharmD with minimum 2 years, or Master’s degree with minimum 4 years of experience.
Preferred: 2–4 years in regulatory medical writing.
Skills:
Proficiency in MS Word and document management software.
Strong expertise in writing clinical regulatory documents.
In-depth knowledge of global drug development regulations and guidelines.
Ability to provide actionable solutions to complex problems.
Skilled in cross-functional collaboration and alignment.
Exceptional written and spoken English proficiency.
Compensation:
Annual Salary Range: $111,000 – $146,000
Bonus Eligibility: Yes
Salary and level determined based on skills, education, experience, and geographic location.
Role Location:
Fully Remote (U.S.-based, Eastern Time Zone preferred)
Note: No relocation assistance or work visa sponsorship available.
Benefits:
Comprehensive Health Insurance (Medical, Dental, Vision, Prescription) from Day 1
401(k) with employer match and defined contribution
Paid Time Off (Vacation, Sick/Safe Time, Caretaker Time, Holidays)
Company-paid Life and Disability Insurance
Employee Stock Purchase Plan
Tuition Assistance
Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs)
Lifestyle Spending Account
Paid Parental Leave
Volunteer Time Off
Family Building Benefits and additional voluntary insurance options
Already Working @ Teva?
If you are a current Teva employee, please apply using the internal career site ("Employee Central") to receive priority consideration. If you encounter access issues, please contact your local HR/IT representative.
Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to equal opportunity in employment and a diverse, inclusive workplace. We ensure non-discrimination based on legally protected statuses. Accommodations are available upon request for the recruitment and selection process.
Important Notice to Employment Agencies:
Teva does not accept unsolicited resumes from agencies without a signed agreement. Any unsolicited resumes will be considered the property of Teva and no fees will be paid.
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