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 and follow and on .
Summary of Position:
The Sr Specialist, Document Control and Training role will support in development and continuous improvement of the Document Control/Management and Training Program at Scholar Rock as we grow and mature organizationally. This individual will maintain documents in compliance with business needs and regulatory standards. This role will report to the Sr Manager, Document Control and Training. Position Responsibilities: Support cross functional teams in processing documents (assist in document editing, review, approvals)Assist in process improvements for Document Control Management/Training processesRevise SOPs related to Document Control/Training on an as needed basis.Help to support the management and maintenance the electronic document management system ensuring Controlled Documents are processed in accordance with Scholar Rock SOPs including creation, revision, approval, and obsoletion of Controlled Documents.Help to support the management and maintenance of the training system ensuring new users are trained, accounts are set up appropriately, and the system remains in a state of compliance.Maintain internal formatting standards and ensure all documentation are formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.Ensure Document Change Requests are created for document revisions and provide appropriate and applicable information on document revisions; creates Document Change Controls for applicable documents. Management of the Document Control/Management and Training Program will require administrative duties such as: Scanning, organizing, and maintaining documents as needed; Collecting and maintaining paper files as needed; Ensuring obsoleted documentation is removed from distribution; Providing support during audits and inspections with respect to document retrieval; Assisting in file migrations; Perform clerical typing duties to generate documents as necessaryOther Quality Operation duties (assisting with internal audits and processing Deviation, CAPA, Change Control), as needed.Candidate Requirements:Minimum of 3-5 years’ experience of Quality Assurance experience in the Pharmaceutical/Biotech Industry.Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.Experience with Veeva Vault required.Experience with ComplianceWire, preferred.Experience in maintaining cGMP compliance, preferred.Excellent organizational skills and the ability to handle multiple priorities and projects.Excellent communication skills with the ability to interact with all levels throughout the organization.Strong written and verbal communication skills as well as attention to detail Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.