Associate Director, Document Management

Job Description

Job Description

Description:

This position is ideal for an experienced document management leader with a passion for compliance, inspection readiness, and operational excellence. The role spans multiple disciplines and serves as a critical link between Quality, Operations, and external partners, requiring a strategic and collaborative leader who can drive best practices across the organization.

This position is ideally based hybrid to Norwood, Ma 3 days per week onsite or we would consider candidates based on east coast USA with monthly travel to Norwood, Ma.

Responsibilities:

• Serve as the business owner and subject matter expert (SME) for document management, driving EDMS governance, inspection readiness, data integrity, and Good Documentation Practice (GDP) across Corbus and its external partners.
• Lead document management strategy and continuous improvement initiatives to support organizational growth, regulatory compliance, operational excellence, and scalable business processes.
• Act as the primary point of escalation and strategic advisor for document management, eTMF, and inspection readiness activities across the organization.
• Provide leadership and oversight for TMF/eTMF health, compliance metrics, risk identification, issue remediation, and inspection preparedness.
• Support audits, regulatory inspections, sponsor oversight activities, and vendor qualification efforts, ensuring documentation and electronic systems remain compliant and inspection ready.
• Partner with Quality Assurance to develop, maintain, and improve SOPs, work instructions, guidance documents, training materials, and associated document management processes.
• Oversee document management activities performed by CROs, CDMOs, and other external partners, ensuring consistent standards, compliance, and inspection readiness.
• Lead the administration and optimization of Veeva Vault and other EDMS platforms, including document lifecycle management, quality control, access governance, validation support, license management, and vendor oversight.
• Lead end-to-end eTMF migration projects, including strategy, metadata mapping, system alignment, quality control, reconciliation, and stakeholder management.
• Develop and deliver training on EDMS platforms, document management processes, and GDP requirements for employees, consultants, and external partners.
• Serve as the designated Archivist, ensuring appropriate retention, retrieval, archival, and disposition of records in accordance with regulatory requirements and company policies.
• Provide reporting and insights to senior management on document management performance, compliance, quality, and timeliness while collaborating across R&D, Quality Assurance, Regulatory Affairs, Clinical Operations, CMC, and IT to drive best practices.

Education and Experience Required:

This role is ideal for an experienced document management professional who thrives in a highly collaborative, regulated environment and enjoys building scalable, inspection-ready processes.

• Bachelor's degree in Life Sciences, a scientific discipline, or a related field. Equivalent combinations of education and relevant experience will be considered.
• Minimum of 10 years’ experience in Clinical Document Management, TMF/eTMF management, Records Management, Clinical Quality, or related GxP-regulated functions with increasing levels of responsibility.
• Demonstrated experience leading document management, inspection readiness, and compliance activities within a biotechnology, pharmaceutical, or CRO environment.
• Strong working knowledge of Veeva Vault applications, including eTMF; experience with system administration, governance, implementation, and/or migration activities is required.
• Thorough understanding of global regulatory requirements and industry guidance, including ICH-GCP, FDA, EMA, MHRA, and ALCOA+ principles for data integrity.
• Strong knowledge of clinical trial documentation (e.g., protocols, investigator brochures, informed consent forms, CRFs, regulatory submissions, and essential documents), as well as regulatory and manufacturing documentation (e.g., INDs, CTAs, IMPDs, CMC documentation, and quality records).
• Solid understanding of the drug development lifecycle and the documentation requirements supporting clinical development, regulatory submissions, manufacturing, and commercialization.
• Demonstrated experience overseeing document management activities performed by CROs, CDMOs, and other external partners within an outsourced operating model.
• Experience supporting regulatory inspections, audits, and sponsor oversight activities, including leading inspection-readiness initiatives and remediation programs.
• Knowledge of electronic document management systems, records management, archival processes, and technologies supporting document control, retention, and retrieval.
• Excellent organizational, communication, and stakeholder management skills, with a proven ability to influence stakeholders and drive compliance-focused initiatives across cross-functional teams.
• Excellent leadership, communication, organizational, and problem-solving skills, with the ability to operate effectively in a fast-paced and evolving biotech environment.

Skills and Aptitude Required:

• Confidence and credibility to act as a subject matter expert (SME), engage with senior leadership, and deliver training and guidance across cross-functional teams and external partners.
• Strong collaboration skills, with the ability to work effectively across global teams, cultures, geographies, and time zones in both remote and hybrid environments.
• Demonstrated ability to lead multiple complex, cross-functional initiatives simultaneously, effectively managing competing priorities and deadlines.
• Highly detail-oriented with exceptional organizational, planning, and time-management skills.
• Proven ability to work independently and exercise sound judgment while also contributing effectively within cross-functional and matrixed team environments.
• Strong problem-solving and critical-thinking skills, with the ability to identify risks, recommend solutions, and drive continuous improvement.
• Advanced proficiency with Microsoft Office applications and demonstrated ability to rapidly learn, adopt, and optimize new technologies and business systems.
• A proactive, service-oriented mindset with a commitment to quality, compliance, and operational excellence.

Corbus Culture:

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in oncology and obesity. Our mission is to help people defeat serious illness by advancing differentiated scientific approaches targeting well-understood biological pathways with significant unmet medical need. Corbus’ lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications. Our obesity program, CRB-913, is a highly peripherally restricted CB1 receptor inverse agonist designed to support meaningful weight loss while minimizing central nervous system side effects. Together, these programs reflect our commitment to advancing transformative therapies through rigorous science and clinical innovation.

Headquartered in Norwood, Massachusetts, Corbus fosters a collaborative, entrepreneurial environment where employees are empowered to make meaningful contributions and help shape the future of the company. For more information, visit corbuspharma.com and connect with us on LinkedIn. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.