Principal Medical Writer (US or Canada) - Nonclinical focus

We are seeking an experienced nonclinical writer to join our Regulatory Strategy team at Fortrea. In this role, you will collaborate with colleagues to support sponsors by preparing summaries of nonclinical data for inclusion in global regulatory filing documents. If you have experience in conducting, interpreting, and/or summarizing nonclinical data from regulated studies or literature reviews, this role may be for you.

Job responsibilities:

• Provide technical leadership with responsibility for preparing the summaries of nonclinical data/information included in global dossiers submitted for review by regulatory and health authorities (eg, IND/CTA, NDA/BLA, MAA)
• Prepare summaries of nonclinical data/information which serves as background documents supporting interactions with regulatory agencies (eg, meeting requests, briefing documents, special protocol assessments)
• Perform nonclinical scientific review on all aspects of work to ensure that data quality and scientific integrity are maintained; provide feedback constructively on relevant issues and initiate process review as appropriate
• Demonstrate detailed knowledge of medical writing industry requirements, such as ICH and regulatory agency guidelines
• Effectively manage multiple assignments in parallel, work independently and with staff from other teams in Fortrea within Regulatory Strategy and external to Regulatory Strategy to ensure preparation of quality documents on time and within budget
• Represent the nonclinical writing perspective during internal and external (ie, with client) discussions prior to project award (eg, capabilities) and after project award (ie, expectations, timelines, and deliverables)
• Provide support for the development of costing estimates and other proposal information related to nonclinical writing
• Work within the Regulatory Strategy team to mentor colleagues and train the associate writing staff
• Highlight and resolve any issues arising from nonclinical writing process(es); work proactively to implement process change, working individually or leading a team as appropriate
• Represent the nonclinical writing perspective on any new technologies being researched globally; have input into feasibility, user requirements, and user acceptance testing

Experience:

• Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
• 8+ years regulatory/medical writing experience (or equivalent), including 3-5 years as a nonclinical writing project lead

• Thorough knowledge of drug development process, including scientific/medical terminology and data analysis and interpretation
• Excellent knowledge of ICH guidelines applicable to regulatory and/or medical writing
• Excellent organizational and time management ability as well as written and verbal communication skills
• Thorough knowledge and command of MS Word

• Excellent command of written and spoken English
• Appreciation of the business requirements of a contract research organization

Preferred Experience:

• Previous research or pharmaceutical experience in conducting, interpreting, and/or summarizing nonclinical data from regulated studies (eg, Study Director), literature reviews, or similar activities
• Nonclinical writing experience focused on advanced therapies

Pay Range: $135,000-$150,000 USD (The range does not include benefits, and if applicable, bonus, commission, or equity)

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.

Application deadline: April 30, 2025

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