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:

In this newly-created position, the Medical Writing Editor will be responsible for overseeing and conducting quality reviews of clinical study and regulatory filing documents to ensure the delivery of clearly written and compliant submission-ready documents. This position requires a highly motivated professional with a passion for science and writing. Key success factors for the position include experience in editing complex scientific and medical material into accurate, concise, consistent text for regulatory, medical, scientific, and lay audiences, a team-centric collaborative mindset, ability to work independently and influence decision-makers, exceptional communication skills, and ability to work well under pressure in a fast-paced environment with tight deadlines.

Position Responsibilities:

Edit documents in support of development programs

Oversee and conduct quality reviews of clinical study and regulatory filing documents (egeg, investigational new drug application and biologics license application components, briefing documents, package inserts, manufacturing reports) to ensure the delivery of clearly written, well-organized, accurate, concise (lean authoring), complete, and compliant submission-ready documents that contain a consistent message, support project goals, are consistent with the document template, and appropriate for their intended audience

Perform copyediting for formatting, style, spelling, and grammar

Perform content QC in documents. Ensure that results are an accurate interpretation of the data.

Create and maintain company- or program-specific document templates that are compliant with the latest guidance

Create and maintain document-specific quality control (QC) checklists

Update and maintain company Style Guide

Develop quality standards for medical writing and associated training materials

Develop training materials for document reviewers

Coordinate Medical Writing inspection readiness activities

Create and maintain Endnote libraries

Track QC findings to identify opportunities for process improvement

Outsource and manage QC work as needed; train vendors on Document Quality processes and quality standards

Candidate Requirements: