Medical Writing Projects Director - Nonclinical
Remote
Development – Medical Writing /
Full-Time /
Remote
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 Medical Writing Projects Director - Nonclinical will be responsible for document development and managing medical writing activities and timelines for nonclinical reports and documents from 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 Authorization Applications) submissions. This position requires a highly motivated professional with experience writing and managing the development of pharmacology, toxicology, Good Laboratory Practice, pharmacokinetics and pharmacodynamics reports, and Module 2 summaries for 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 pharmacology, toxicology, PK/PD, GLP and bioanalytical reports (Module 4) as well as nonclinical sections of regulatory documents including, nonclinical Module 2 summaries, regulatory briefing documents, and nonclinical 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:
- Ph.D. or equivalent level of experience in toxicology, pharmacology, drug metabolism and pharmacokinetics, or related biomedical/life sciences discipline.
- 10+ years of experience in medical writing within the pharmaceutical/biotech industry, with at least 5+years at a sponsor company
- 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 Module 4 nonclinical documents and Module 2 summariesfor drug marketing applications
- 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.
