Senior Manager - Medical Writing

February 4

Apply Now

Receive Emails with Similar Jobs

Scholar Rock

WebsiteLinkedInAll Job Openings

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a

51 - 200 employees

Founded 2016

💰 $205M Post-IPO Equity on 2022-06

📋 Description

• Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. • As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. • This position requires a highly motivated professional with experience in submitting successful drug marketing applications. • Key success factors include project management skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines.

🎯 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