Senior Manager, Medical Writing

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as a Senior Manager, Medical Writing. You will be responsible for creating and managing regulatory and clinical documents for drug marketing applications, both in the US and internationally. This role requires strong project management and scientific writing skills, collaboration with cross-functional teams, and experience in successful drug application submissions. The ideal candidate will have an advanced degree in a relevant scientific field and 7+ years of experience in regulatory/development medical writing within the pharmaceutical/biotech industry. Success in this position hinges on your ability to lead writing teams, manage timelines, and work effectively in a fast-paced environment.

Requirements

• Advanced degree in a relevant scientific field preferred; Bachelor of Science in a relevant scientific field required
• 7+ years of experience in regulatory/development medical writing within the pharmaceutical/biotech industry, with at least 4+ years at a sponsor company; experience with nonclinical, clinical pharmacology and/or devices is a plus
• Experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA) health authorities
• Extremely strong project management skills; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Strong knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
• Strong knowledge of requirements for the preparation of documents for drug marketing applications and for annual maintenance of clinical development programs (Investigator’s Brochures, Annual Reports, Clinical Study Reports)
• Ability to work independently in a fast-paced, small biotech corporate environment
• Ability to be creative and innovative
• Common sense

Responsibilities

• Create and manage development of regulatory and clinical documents including protocols, Investigator's Brochures (IBs), development safety update reports (DSURs), clinical study reports (CSRs), regulatory briefing documents, and clinical sections of regulatory submissions
• Lead project-level writing teams with minimal supervision
• Collaborate with cross-functional teams to drive document development, reviews, and timelines with a sense of urgency to meet aggressive corporate goals
• Lead and manage senior-level subject matter experts in the development of complex documents
• Represent Medical Writing on cross-functional teams and workstreams