Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)
Date: March 7, 2025
Location: West Chester, Pennsylvania, 19380, United States
Company: Teva Pharmaceuticals
Job Id: 59604
Who We Are:
Teva Pharmaceuticals is dedicated to making good health more affordable and accessible, impacting millions of lives across nearly 60 countries. As the world’s leading manufacturer of generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List, Teva strives to find new ways to make a difference.
The Opportunity:
As a Manager in Global Regulatory Medical Writing, you will be responsible for writing and editing high-quality clinical regulatory documents, including submission summaries and other complex materials critical for drug development and product registrations. You will also provide guidance and oversee resources to ensure the seamless production of clinical research documentation supporting innovative healthcare solutions.
How You’ll Spend Your Day:
Write and edit clinical regulatory documents, including submission summaries and other complex documents.
Lead author for clinical regulatory documents, including:
Protocols
Clinical study reports
CTD Clinical Overview M2.5 and Clinical Summaries M2.7.1, M2.7.2, M2.7.3, and M2.7.4
ISS/ISE
Investigator brochures
Briefing documents
Responses to regulatory authority questions
Other Responsibilities:
Work independently with minimal supervision.
Apply statistical and regulatory concepts to clinical regulatory documents.
Manage multiple documents simultaneously as the lead writer.
Offer strategic assistance and planning support for clinical regulatory documents.
Collaborate with cross-functional teams to ensure high-quality document production within timelines.
Lead comment resolution meetings to address issues and guide the team to successful resolution.
Contribute to the preparation and revision of document templates for process efficiency.
Ensure documents include accurate medical/scientific messaging and adhere to regulatory guidelines.
Manage contingent workers and/or vendors, providing training and resource management support.
Your Experience and Qualifications:
PhD or PharmD in Life Sciences (or related field) with at least 2 years of experience, OR
Master’s degree in Life Sciences (or related field) with at least 4 years of experience.
Preferred experience: 2-4 years in regulatory medical writing.
Proficiency in MS Word and advanced use of software, templates, and electronic formats for document preparation.
Expertise in writing and editing clinical regulatory documents, including submission summaries.
Strong knowledge of global regulatory guidelines, government regulations, and statistical concepts.
Proven ability to develop strategies and provide actionable solutions for complex problems.
Strong communication skills to drive alignment and deliver results.
Compensation:
Annual starting salary between $111,000 - $146,000, depending on geography, skills, education, experience, and qualifications.
Potential for bonus eligibility.
Role Location:
US-Based Remote (Eastern Time Zone Preferred)
Relocation assistance and work visa sponsorship not available.
Enjoy a More Rewarding Choice:
Teva offers a competitive benefits package, including:
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage from the first day of employment.
Retirement Savings: 401(k) with employer match up to 6% and an annual 3.75% Defined Contribution to the plan.
Paid Time Off: Vacation, sick/safe time, caretaker time, 13 paid holidays, and 3 floating holidays.
Life and Disability Protection: Company-paid Life and Disability insurance.
Additional Benefits: Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Volunteer Time Off, Paid Parental Leave (if eligible), and more.
Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is an equal opportunity employer and is committed to providing equal employment opportunities without discrimination based on age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity, ancestry, veteran status, or national/ethnic origin.
Important Notice to Employment Agencies:
Teva Pharmaceuticals does not accept unsolicited assistance from agencies for employment opportunities. All CVs/resumes submitted by search firms without a valid written agreement will be deemed the sole property of the company.
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China | Quarry Bay |Hubei :
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