Director, Global Regulatory Operations, RIMS/DMS Lead at Sarepta Therapeutics in Cambridge, Massachusetts

Job Description:

The Director, Global Regulatory Operations, RIMS/DMS Lead has responsibility for assuring the effective deployment and advancement of Sarepta's Registration and Document management system across the organization and with key stakeholders.

Responsibilities:

• Build and support expansion and long-term strategies for registration and document management to meet Sarepta Therapeutics' goals to rapidly bring treatments to patients with rare genetic diseases


• Successfully lead ongoing deployment and advancement of Sarepta's RIMS/DMS platform with key stake holder functions, including Research and Development, Technical Operations, Program Management, Commercial and others.


• Formalize and deliver relevant Regulatory Operations and cross functional processes and procedures and drive collaborations for enhanced efficiency through RIMS/DMS adoption across Research and Development, Technical Operations, Program Management and elsewhere as needed.


• Assure secure access to the RIMS/DMS system for identified partners to support effective collaboration.


• Ensure compliance with company policies, existing regulations and regulatory guidelines.


• Enhance reporting and commitment tracking within the RIMS/DMS system.


• Track all submission and health authority activity to aid in resource planning for R&D submissions.


• Effectively manage the change control process for enhancements of the RIMS/DMS system and work cross functionally with IT and Quality to assure effective and timely deployment of thrice yearly and ad hoc system upgrades.


• Effectively interface with colleagues in Quality, Clinical Operations, IT and others to assure that GXP RIMS/DMS systems appropriately interface with other GXP systems, including electronic TMF and electronic change control and process management for efficient information sharing and collaboration.

Qualifications:

• 10 years of relevant experience with demonstrated expertise in document management, Regulatory Information Management, archiving and metrics analysis


• BA or BS degree or equivalent


• Experience driving organizational change management, adoption of new systems and processes, and enhanced organizational efficiency and productivity


• Experience with multiple platforms and systems to support RIMS and DMS


• Experience with Veeva RIMS/DMS change controls, security model and effective partnering with IT for successful implementation, integrations and upgrades


• Demonstrated understanding of global eCTD compliance and other EDM regulations and laws critical for regulatory compliance


• Demonstrated success in training direct reports and staff members at all organizational levels


• Excellent cross functional communicator with excellent verbal, written, organizational, time management skills and attention to detail. Ability to prioritize and balance multiple competing priorities simultaneously


• Extensive experience solving complex problems

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.