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

4+ years

Not Disclosed

Macon

10 April 18, 2025

Job Description

Job Type: Full Time Education: 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: Apr 5, 2025
Location: Macon, United States, New Hampshire, 10903
Company: Teva Pharmaceuticals
Job Id: 59605

Who we are:
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. We’re always looking for new ways to continue making a difference, and new people to make a difference with.

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:
Product and Program-Level Responsibilities

Provide leadership and accountability for key regulatory documents.
Potentially oversee direct reports, contingent workers, and/or vendors, while also 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 align 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:
The annual starting salary for this position is between $121,000 - 159,000. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

This position may also be eligible for a bonus. Level of the role will be commensurate to years of experience and performance criteria.

Role location:
US-Based Remote (US 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 on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays, and 3 paid floating holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but not limited to, 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, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided 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 recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Important notice to Employment Agencies - Please Read Carefully:
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position-specific. Please, no phone calls or emails.

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

Job Description

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