Sr Medical Writer - Regulatory Submission Experience Required (Home-Based, Us Locations)

Syneos Health

3-5 years

$80,600 – $145,000

Remote, USA

10 Sept. 9, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Job Description – Senior Medical Writer (Regulatory Submissions)

Company: Syneos Health
Location: Remote (U.S. – NC or other U.S. locations)
Job ID: 25100622
Updated: September 6, 2025
Job Type: Full-time
Salary Range: $80,600 – $145,000

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, working across clinical development, medical affairs, and commercialization to accelerate the delivery of therapies. With over 29,000 employees in 110 countries, Syneos Health has partnered in the development of 94% of all novel FDA-approved drugs in the last five years.

Culture & Values:

Total Self Culture – encourages authenticity and inclusivity.
Focus on career development, mentorship, and progression.
Recognition programs and competitive rewards.

Position Overview

The Senior Medical Writer will lead the creation and delivery of clear, accurate, and regulatory-compliant medical writing documents. This role requires expertise in regulatory submissions, ICH/FDA guidelines, and scientific communication, while managing writing activities across studies with minimal supervision.

Key Responsibilities

Medical Writing & Documentation

Lead the completion of medical writing deliverables with accuracy and clarity.
Author and edit a wide range of documents, including:
- Clinical study protocols & amendments
- Clinical study reports (CSRs) & patient narratives
- Annual reports, investigator brochures, informed consent forms
- Plain language summaries
- Periodic safety update reports (PSURs)
- Clinical development plans
- IND, NDA, eCTD submissions, and integrated summary reports
- Journal manuscripts, abstracts, posters, and scientific presentations

Compliance & Quality

Ensure adherence to ICH E3 guidelines, FDA regulations, AMA Manual of Style, and company/client SOPs.
Coordinate and perform quality checks and editorial reviews.
Manage source documentation and maintain compliance with copyright laws.

Collaboration & Review

Partner with cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs.
Review statistical analysis plans, tables/figures/listings for clarity, format, and consistency.
Act as a peer reviewer for internal teams to ensure scientific accuracy and document consistency.

Leadership & Mentorship

Mentor and support junior medical writers on complex projects.
Provide technical training and consultation to team members.
Identify and resolve document-related issues, offering innovative solutions.

Research & Expertise

Conduct systematic literature reviews to support document development.
Develop deep expertise in therapeutic areas, regulatory requirements, and industry best practices.
Stay updated on evolving regulatory standards and medical writing trends.

Qualifications

Education

Bachelor’s degree in life sciences, pharmacy, medicine, or related field (Master’s or higher preferred).

Experience

3–5 years of medical writing experience in the biopharmaceutical, device, or CRO industry.
Proven experience in regulatory submission documents.
Strong knowledge of FDA, ICH, and global regulatory guidelines.

Skills

Strong command of English grammar and AMA Manual of Style.
Advanced proficiency in MS Office Suite.
Excellent project management, time management, and organizational skills.
Strong presentation, proofreading, and collaborative skills.
Ability to interpret complex clinical and statistical data.

Compensation & Benefits

Competitive base salary ($80,600 – $145,000).
Performance-based bonuses and commission eligibility.
Health benefits: Medical, Dental, Vision.
401(k) with company match & Employee Stock Purchase Plan.
Flexible paid time off (PTO) and sick leave (state-specific variations apply).
Additional benefits may include company car or car allowance.

Impact & Contribution

This role ensures regulatory submission success by delivering high-quality clinical and regulatory documents. Senior Medical Writers at Syneos Health play a vital role in enabling timely drug approvals and advancing patient access to new therapies.

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Sr Medical Writer - Regulatory Submission Experience Required (Home-Based, Us Locations)

Job Description

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