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

4-6 years

Not Disclosed

Macon

10 April 25, 2025

Job Description

Job Type: Full Time Education: M.Sc./M.Pharm/PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)
Location: Macon, United States, New Hampshire, 10903
Company: Teva Pharmaceuticals
Job ID: 59605
Date: April 5, 2025

About Teva Pharmaceuticals:
Teva Pharmaceuticals is committed to making health more affordable and accessible, helping millions around the world lead healthier lives. As the world’s leading manufacturer of generic medicines, Teva provides essential medications listed by the World Health Organization. At least 200 million people rely on Teva’s medicines every day, and the company continues to innovate with a diverse global workforce working together to improve health outcomes.

Role Overview:
Teva is seeking a Senior Manager in Global Regulatory Medical Writing. This individual will be responsible for writing and editing clinical regulatory documents, such as submission summaries and other critical materials, necessary for drug development and product registrations. You will provide intermediate-level oversight and leadership, ensuring that high-quality clinical research documentation is produced efficiently.

Key Responsibilities:

Leadership & Oversight:
- Oversee the development of key regulatory documents, ensuring leadership and accountability.
- Potentially supervise direct reports, contingent workers, and/or vendors while providing training and resource management support.
- Provide strategic planning and leadership to enhance the development of clinical regulatory documents.
Writing & Editing:
- Write and edit clinical regulatory documents, ensuring clarity, consistency, and alignment with regulatory guidelines and editorial standards.
- Ensure documents are accurate, complete, and contain the appropriate scientific context and messaging.
- Contribute to the preparation and revision of document templates to streamline process efficiency and quality.

Qualifications:

Education & Experience:
- PhD or PharmD in Life Sciences (or related field) with at least 4 years of experience, or Master’s degree in Life Sciences (or related field) with at least 6 years of experience.
- Preferred experience: 4-6 years in regulatory medical writing.
Skills & Expertise:
- Proficient in Microsoft Word and experience with software, templates, and electronic formats for document preparation.
- Advanced expertise in regulatory medical writing with experience in managing clinical regulatory documents.
- Strong knowledge of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.
- Excellent proficiency in English, both written and spoken.

Compensation:

The annual starting salary for this position ranges from $121,000 - $159,000, depending on factors such as geography, market, experience, and qualifications.
The position may also include eligibility for a bonus.

Role Location:

US-Based Remote (US Eastern time zone preferred)

Relocation Assistance & Work Visa:

Relocation assistance and work visa sponsorship are not available.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals promotes diversity and inclusion, offering equal opportunities to all applicants regardless of race, gender, disability, and other protected statuses. Accommodation is available throughout the recruitment process to support accessibility for candidates.

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

Job Description

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