Principal Medical Writer (Sponsor Dedicated) - Us Or Canada

Fortrea

5+ years

$125,000 - $145,000 USD

Durham

11 Nov. 25, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Principal Medical Writer
Locations: Durham, NC | Remote (Canada or United States)
Time Type: Full-Time

About Fortrea

Fortrea is a global leader in clinical research, providing cutting-edge solutions to pharmaceutical, biotechnology, and medical device companies. With a presence in over 90 countries, we are dedicated to accelerating the delivery of life-changing therapies to patients worldwide.

Join us in our mission to shape the future of healthcare through clinical innovation.

Position Overview

Fortrea seeks an experienced Principal Medical Writer to join a dynamic team supporting one sponsor. This is a strategic role focused on authoring and developing complex clinical regulatory documents, aligning with project strategies, and facilitating seamless collaboration among stakeholders.

This full-time, remote-based position is open to candidates in the US and Canada.

Key Responsibilities

Expert Contributor

Author and develop complex clinical regulatory documents, including:
- Clinical Study Protocols and Reports
- Investigator Brochures
- Clinical summary modules and overviews in CTD/eCTD format
Provide expertise in regulatory submissions globally.

Strategist

Drive document development that aligns with project strategies and objectives.
Lead initiatives to ensure written materials support overarching project goals.

Project Manager

Serve as the primary liaison between teams, managing writing projects and leading collaborative discussions.
Foster decision-making processes, facilitate stakeholder consensus, and advance document development.
Ensure timely and high-quality delivery of medical writing outputs.

Qualifications

Education:
- Advanced degree (PhD or Master’s) in a relevant field.
Experience:
- Minimum of 6 years in eCTD submission writing, with at least 3 years as a medical writing project lead.
- Proven experience in developing a wide range of clinical regulatory documents.
- Expertise in leading content for efficacy/safety clinical summary modules and drug applications across regions.
Skills:
- Strong leadership, communication, and project management skills.
- Proactive collaboration with cross-functional teams.
- Adaptability to diverse therapeutic areas and augmented responsibilities.

Why Choose Fortrea?

Diverse Career Paths

Stay immersed in medical writing or transition to management roles with training and support.

Compensation & Benefits (US only)

Pay Range: $125,000 - $145,000 USD
Comprehensive benefits package, including:
- Medical, Dental, Vision
- Life Insurance, STD/LTD, 401(K), ESPP
- PTO or Flexible Time Off (FTO)
- Company Bonus (where applicable)

How to Apply

Visit www.fortrea.com to submit your application. Reference job requisition ID: 2439821. The application deadline is December 13, 2024.

Fortrea is committed to diversity, equity, and inclusion. We welcome all qualified applicants and ensure a discrimination-free environment.

For detailed information about our data practices, please review our Privacy Statement.

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