Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)

Lensa; West Chester (Chester County); Remote; USD 111,000 - 146,000; Full time

Job summary

A leading pharmaceutical company is seeking a Manager in Global Regulatory Medical Writing to craft high-quality clinical documents essential for drug development. This remote role requires expertise in regulatory writing and offers a competitive salary and comprehensive benefits.

Benefits

Comprehensive health insurance

Retirement plan with employer match

Paid time off

Life and disability insurance

Tuition assistance

Qualifications

• Minimum 2 years (PhD/PharmD) or 4 years (Master’s) of regulatory medical writing experience.
• Expertise in writing/editing complex regulatory documents.

Responsibilities

• Lead author for clinical regulatory documents, including protocols and study reports.
• Collaborate with cross-functional teams to ensure timely, high-quality document production.

Skills

Communication

Problem Solving

Leadership

Education

PhD or PharmD in Life Sciences

Master’s degree with relevant experience

Tools

Microsoft Word

Job description

Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)

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Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)

Date: May 4, 2025

Location: West Chester, Pennsylvania, 19380, United States

Company: Teva Pharmaceuticals

Job Id: 59604

Who We Are

Together, we’re on a mission to make good health more affordable and accessible, helping millions worldwide enjoy healthier lives. Our diverse team spans nearly 60 countries, working with the world’s leading manufacturer of generic medicines, including many on the WHO’s Essential Medicines List. Over 200 million people take our medicines daily. We aim to keep making a difference and seek talented individuals to join us.

The Opportunity

As a Manager in Global Regulatory Medical Writing, you will craft and edit high-quality clinical regulatory documents, such as submission summaries and complex materials essential for drug development and registration. You will also provide guidance, oversight, and resource management to ensure seamless documentation supporting our healthcare solutions.

Daily Responsibilities

• Lead author for clinical regulatory documents, including protocols, clinical study reports, CTD summaries, ISS/ISE, investigator brochures, briefing documents, and responses to regulatory questions.
• Work independently with minimal supervision as an individual contributor.
• Apply statistical and regulatory concepts effectively in document writing.
• Manage multiple documents simultaneously, providing strategic guidance and planning support.
• Collaborate with cross-functional teams to ensure timely, high-quality document production.
• Lead comment resolution meetings and guide teams to successful outcomes.
• Contribute to template development to improve process efficiency and quality.
• Ensure documents contain accurate, clear, and consistent scientific messaging, adhering to regulatory and editorial standards.
• May oversee contingent workers and vendors, providing training and resource management support.

Qualifications & Experience

• PhD or PharmD in Life Sciences or related field, or Master’s degree with relevant experience.
• Minimum 2 years (PhD/PharmD) or 4 years (Master’s) of regulatory medical writing experience.
• Proficiency in Microsoft Word, templates, and electronic document formats.
• Expertise in writing/editing complex regulatory documents.
• Knowledge of drug development regulations, global submission guidelines, and statistical concepts.
• Ability to develop strategies, solve complex problems, and communicate effectively.
• Understanding of global submission regulations and guidelines.
• Experience in process improvement, budget planning, and team leadership.
• Exceptional English communication skills, both written and spoken.

Compensation

The annual salary ranges from $111,000 to $146,000, influenced by location, skills, education, and experience. The role may include bonuses, with level based on experience and performance.

Location & Additional Details

Remote in the US, preferably US Eastern time zone. Relocation assistance and work visa sponsorship are not provided.

Benefits

• Comprehensive health insurance (medical, dental, vision, prescriptions).
• Retirement plan with employer match and contributions.
• Paid time off, holidays, and floating holidays.
• Life and disability insurance.
• Additional perks like Employee Assistance Program, stock purchase, tuition assistance, and more.

Current Employees

If you are a Teva employee, apply via the internal career site for priority consideration: Internal Career Site.

EEO Statement

Teva is committed to equal employment opportunities and a diverse, inclusive workplace. We provide accommodations for applicants with disabilities throughout the recruitment process.

Agency Policy

We do not accept unsolicited agency referrals without a valid agreement. All submissions by agencies without an agreement will be considered property of Teva, with no fee paid.