Scholar Rock is a Phase 3, 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 selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
Our Senior Director, Head of Medical Writing will be responsible for building Medical Writing capabilities in support of multiple clinical programs across all phases of development, including late-phase Biologics License Application (BLA) activities. The successful candidate will also be capable of playing a ‘hands-on’ role in the development and delivery of clinical and regulatory documents as needed. This position requires a highly motivated and enthusiastic professional with expertise throughout the product lifecycle. Key success factors for the position include proven track record in overseeing Medical Writing teams and the delivery of high-quality submission-ready documents. In addition, this role requires creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, and the ability to inspire. This position reports to the SVP, Regulatory Affairs and Quality.
Management, oversight, and operation of medical writing team responsible for development of clinical and regulatory documents
Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)
Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
Independently author and manage others in creation of clear and concise submission-ready documents
Act as subject matter expert for development of data transparency deliverables
Develop and maintain SOPs, style guides, and quality control checklists that drive consistency across documents and processes
Build and mentor medical writing team
Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections
Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
Advanced degree in life sciences preferred; minimum BS/BA required
10+ years’ experience in a medical writing capacity within drug development
Prior direct experience leading medical writing teams responsible for global marketing authorization applications
Extensive knowledge of English grammar and American Medical Association style guide
Demonstrated experience mentoring medical writers, managing project work of internal medical writers, and supervising external (contract/vendor) writers
Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
Proactive team player, collaborative, and flexible
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.