Principal Safety Writer

2+ years

Not Disclosed

Remote, USA

10 Oct. 30, 2024

Job Description

Job Type: Full Time 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

Company Overview

Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, we are transforming drug and device development for partners and patients worldwide.

Job Overview

We are seeking a skilled Medical Writer to lead the preparation and review of aggregate safety reports, risk management documents, and benefit-risk evaluations. This role involves independently managing the production of complex safety deliverables and serving as the technical lead for medical writing teams across projects. The successful candidate will ensure high-quality scientific content, foster effective communication with clients, and manage stakeholder expectations.

Summary of Responsibilities

Write and review safety reports for global regulatory submissions, including Annual Reports (IND), Periodic Safety Update Reports, and Clinical Overviews.
Oversee the report production process, ensuring quality standards and timelines are met while guiding co-authors and writers.
Act as the primary client contact for report management activities, addressing challenges and escalating issues as necessary.
Author/review Risk Management Plans (RMPs), Benefit-Risk Evaluation reports, and safety issue analysis reports.
Participate in signal management processes and collaborate on safety analyses with clients.
Draft responses to health authority inquiries and coordinate with cross-functional teams.
Develop abstracts, posters, and manuscripts for scientific publication and presentations at conferences.
Provide coaching and training to team members on clear writing practices and adherence to style guides.
Support project management activities, including schedule maintenance and compliance tracking.
Contribute to business development, resource estimation, and response to RFPs.
Conduct literature reviews and implement efficient processes to ensure timely deliverables.
Ensure operations comply with regulatory requirements and maintain high customer service standards.
Perform additional tasks as needed based on project requirements or management discretion.

Qualifications (Minimum Required)

A minimum of a first degree in life sciences (or equivalent). Relevant experience may substitute for educational requirements.

Experience (Minimum Required)

At least 5-7 years of experience in the pharmaceutical industry, including 4 years in medical writing.
Proficient in written and spoken English with strong communication skills.
Knowledge of MS Office and excellent organizational abilities.
Proven interpersonal and leadership skills.
Familiarity with regulatory requirements, good Pharmacovigilance practices, and ICH-GCP guidelines.
Comprehensive understanding of the pharmaceutical product development cycle and regulatory submission guidelines for the US, EU, and emerging markets.
Ability to work independently and mentor team members effectively.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our commitment to overcoming barriers in clinical trials. We strive to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We are committed to diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

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Principal Safety Writer

Job Description

Company Overview

Job Overview

Summary of Responsibilities

Qualifications (Minimum Required)

Experience (Minimum Required)

Join Us

Equal Opportunity Employer

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