Job Overview
Location
Cambridge, MA
Job Type
Full-time
Category
HR & Recruiting
Date Posted
July 9, 2026
Full Job Description
đź“‹ Description
- • Develop and maintain a comprehensive understanding of clinical operations compliance, including regulatory requirements, industry standards, and company policies.
- • Collaborate with cross-functional teams, including clinical operations, regulatory, and quality assurance, to ensure compliance with regulatory requirements and company policies.
- • Develop and implement procedures to ensure compliance with regulatory requirements, industry standards, and company policies.
- • Provide training and support to clinical operations teams on compliance procedures and regulatory requirements.
- • Identify and manage compliance risks, and develop and implement corrective actions to mitigate these risks.
- • Develop and maintain a compliance program that is aligned with company policies and regulatory requirements.
- • Collaborate with the Head of Clinical Operations to develop and implement a compliance strategy that aligns with company goals and objectives.
- • Provide regular updates to the Head of Clinical Operations on compliance status and any issues that may arise.
- • Develop and maintain a compliance dashboard to track compliance metrics and key performance indicators.
- • Collaborate with the quality assurance team to ensure compliance with quality management system requirements.
- • Develop and implement procedures to ensure compliance with data management and data protection regulations.
- • Collaborate with the regulatory team to ensure compliance with regulatory requirements and industry standards.
- • Develop and maintain a compliance manual that outlines company policies and procedures.
- • Collaborate with the quality assurance team to ensure compliance with quality management system requirements.
🎯 Requirements
- • Bachelor's degree in a life science, regulatory affairs, or a related field.
- • Minimum 5 years of experience in clinical operations compliance, regulatory affairs, or a related field.
- • Strong knowledge of regulatory requirements, industry standards, and company policies.
- • Excellent communication and interpersonal skills.
- • Ability to work in a fast-paced environment and prioritize multiple tasks.
🏖️ Benefits
- • Competitive salary and benefits package.
- • Opportunities for professional growth and development.
- • Collaborative and dynamic work environment.
- • Recognition and rewards for outstanding performance.
Skills & Technologies
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About Scholar Rock Holding Corporation
Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company focused on discovering and developing innovative medicines targeting the latent transforming growth factor-beta (TGFβ) superfamily. The company leverages its proprietary platform to selectively modulate growth factors implicated in disease pathways, advancing therapies for neuromuscular, fibrotic, and other serious conditions. Its lead product candidate, apitegromab, is in Phase 3 trials for spinal muscular atrophy (SMA).
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