Offer summary

Qualifications:

Ph.D. or equivalent experience in toxicology, pharmacology, or related biomedical sciences., 10+ years of medical writing experience in the pharmaceutical/biotech industry, with 5+ years at a sponsor company., Strong knowledge of biologics drug development and regulatory requirements for drug marketing applications., Exceptional project management and communication skills, with the ability to work independently in a fast-paced environment..

Key responsabilities:

Manage the development of pharmacology, toxicology, and bioanalytical reports for regulatory submissions.

Lead project-level writing teams and collaborate with cross-functional teams to meet aggressive timelines.

Oversee the creation of nonclinical sections of regulatory documents and represent Medical Writing on cross-functional teams.

Ensure high-quality document preparation while managing senior-level subject matter experts.

Job 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 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 managedevelopment of pharmacology, toxicology, PK/PD, GLP and bioanalyticalreports (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.

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