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

4-6 years

Not Disclosed

Macon

10 March 26, 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)
Date: Mar 7, 2025
Location: Macon, New Hampshire, United States, 10903
Company: Teva Pharmaceuticals
Job Id: 59605

Who We Are

Together, we’re on a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. We operate in nearly 60 countries, with a diverse range of nationalities and backgrounds. As the world’s leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization’s Essential Medicines List, we ensure that over 200 million people worldwide take one of our medicines every day. We continuously seek innovative ways to make a difference and welcome new people to join us in this mission.

The Opportunity

As a Senior Manager in Global Regulatory Medical Writing, you will write and edit clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. You will provide intermediate-level oversight, guidance, and resource management to ensure the effective production of high-quality clinical research documentation.

How You’ll Spend Your Day

Focus on product and program-level responsibilities, providing leadership and accountability for key regulatory documents.
Potentially oversee direct reports, contingent workers, and/or vendors, while offering training and resource management support.
Provide strategic supervision, leadership, and planning for the development of clinical regulatory documents.
Write and edit various types of clinical regulatory documents, ensuring content is accurate, complete, and adheres to regulatory guidelines and editorial standards.
Ensure documents are clear, consistent, and aligned with regulatory medical writing best practices, including appropriate context and scientific messaging.
Contribute to the preparation and revision of document templates, enhancing process efficiency and quality.

Your Experience and Qualifications

PhD or PharmD in Life Sciences (or related field) with a minimum of 4 years of experience, or a 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.
Proficient in Microsoft (MS) Word and adept at using software, templates, and electronic formats for document preparation.
Recognized as a competent manager with advanced expertise in regulatory medical writing.
Skilled in writing and editing various types of clinical regulatory documents, ensuring clarity, accuracy, and compliance with regulatory guidelines.
Advanced understanding of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.
Strong English language proficiency, both written and spoken.

Compensation

Annual Salary Range: $121,000 - $159,000 (based on geography, skills, education, experience, and qualifications).
Bonus Eligibility: This position may also be eligible for bonus based on performance.
Role Level: Commensurate with years of experience and performance criteria.

Role Location

US-Based Remote (Eastern time zone preferred).
Relocation Assistance and Work Visa Sponsorship: Not available.

Enjoy a More Rewarding Choice

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting from day one.
Retirement Savings: 401(k) with employer match (up to 6%) and an annual 3.75% Defined Contribution to the 401(k) plan.
Time Off: Paid Time Off, including 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, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave (if eligible), Family Building Benefits, Virtual Physical Therapy, and various other insurances.

Already Working @TEVA?

If you are a current Teva employee, apply through the internal career site available on "Employee Central." By doing so, your application will be treated with priority. If you encounter issues accessing your EC account, contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. We provide equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally protected status. We are dedicated to a diverse and inclusive workplace.

Important Notice to Employment Agencies

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs/resumes submitted by search firms to any employee without a valid written search agreement in place will be considered the sole property of Teva. No fee will be paid in the event a candidate is hired as a result of an agency referral where no pre-existing agreement exists.

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

Job Description

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