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Mgr, Medical Writing

0-2 years
$95,000 – $175,700
10 Nov. 12, 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 Title: Manager, Medical Writing (Remote-Based)

Location: USA – NC – Remote
Job ID: 25102381
Updated: October 14, 2025


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities.

  • Employees: 29,000 across 110 countries

  • Impact: Supported 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites in the past 5 years

  • Culture: Inclusive “Total Self” culture encouraging authenticity, diversity, and belonging

Learn more: Syneos Health


Why Syneos Health

  • Career development and progression opportunities

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • Flexible Paid Time Off (PTO) and sick leave (state-dependent)

  • Health benefits: Medical, Dental, Vision

  • Company car or car allowance (where applicable)


Job Summary

The Manager, Medical Writing leads and manages medical writing staff, ensuring high-quality deliverables, adherence to regulatory standards, and alignment with sponsor objectives. This role combines team leadership, project oversight, business development support, and hands-on medical writing review.


Key Responsibilities

Team Leadership & Management

  • Manage medical writing staff, including hiring, performance reviews, professional development, and mentoring

  • Advise staff on administrative policies, technical challenges, and work prioritization

  • Review performance of direct reports and maintain departmental SOPs and templates

Project & Quality Oversight

  • Review and edit departmental work products for completeness, accuracy, and quality

  • Ensure adherence to sponsor objectives and quality standards

  • Perform senior reviews of medical writing deliverables, statistical analysis plans, and tables/figures/listings

  • Participate in planning, writing, and assembly of medical writing deliverables

Business & Operations Support

  • Assist with budgeting, revenue, invoicing, and forecasting for medical writing projects

  • Support business development, proposal/costing development, bid defenses, and customer meetings

  • Track and maintain departmental/project metrics

  • Form and lead cross-functional teams, resolving issues as they arise

Regulatory & Compliance

  • Ensure compliance with FDA, EU, ICH regulations, ISO standards, and internal policies

  • Maintain up-to-date knowledge of clinical research principles and regulatory guidelines

Other Duties

  • Perform additional work-related duties as assigned

  • Minimal travel may be required (up to 25%)


Qualifications

  • Bachelor’s degree in a relevant scientific or medical field

  • Experience in medical writing, preferably with progressive management experience in a CRO, pharmaceutical, or medical device company

  • Extensive knowledge of English grammar and regulatory standards (FDA, ICH)

  • Strong understanding of clinical research principles and ISO standards

  • Excellent communication, presentation, interpersonal, and leadership skills

  • Proficiency in Microsoft Office Suite


Salary & Benefits

  • Salary Range: $95,000 – $175,700 (based on experience, skills, and qualifications)

  • Benefits may include:

    • Medical, Dental, Vision insurance

    • Company car or car allowance

    • 401(k) with company match

    • Employee Stock Purchase Plan

    • Flexible PTO and sick leave

    • Eligibility for performance-based commissions/bonuses


Additional Information

  • This posting may represent a potential future opportunity; expressing interest adds candidates to the talent pipeline

  • Tasks and responsibilities are not exhaustive; equivalent experience may be considered

  • Compliance with ADA regulations and reasonable accommodations provided


How to Apply

  • Apply Now or join the Syneos Health Talent Network to stay connected to future opportunities