Scholar Rock

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 and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The Senior Manager, Medical Writing will be responsible for document development and managing medical writing activities and timelines for clinical and regulatory/health authority drug marketing applications, including US (Investigational New Drug [applications], New Drug Applications, Biologics Licensing Applications) and ex‑US (Clinical Trial Applications, Marketing Authorisation Applications) submissions. 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.

Position 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.

Candidate 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.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.