Title: Records Manager
Location: Basking Ridge, NJ
Pay Rate: $42.85
Duration: 6 month contract
Reason: Vacant Position
Department: Clinical Development Operations
Responsible for ensuring that records are handled and maintained to the required standards by maintaining awareness of current regulatory, legal, and other relevant guidelines. Deliver on the strategy for Records Management, ensuring the operational aspects are handled daily. Oversee storage system for both electronic and existing paper documents that will allow for identification and retrieval of documents in support of the trial master file as well as DSPD records across the organization. Ensures compliance in how DSPD and TMF stores, retrieves, refiles, destroys records with high standards and minimal supervision. Interact with external vendors related to Records Management on behalf of Daiichi Sankyo. Work with the Corporate functions and Legal Affairs to carry out the aims of the Records Management Program across DSI.
- Manages and oversees quality within Records Management and associated business process, looking for improvement opportunities and relentlessly seeking to translate improvement opportunities into realities.
- Maintain Standard Operating Procedures (SOPs) and Work Instructions for job function within Records Management, discovering and documenting process improvements.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and internal client requests for records.
- Lead awareness efforts and promote/educate employees on Records Management, associated business quality and compliance.
- Recommending the decisions for accurate Legal Hold requirements and destruction of global records based on corporate retention guidelines.
- Performing yearly testing of both the DSPD and TMF processes to ensure success during both audits and inspections.
- Project management experience.
- A thorough knowledge and understanding of GxP/GCP Records Management is required, including retention requirements and systems utilized in records management for the pharmaceutical industry.
- Self-sufficient, self-motivated, excellent leadership skills, able to prioritize and delegate, detail-oriented, good interpersonal skills, ability to effectively communicate in writing and orally with peers and upper management.
- Advanced computer skills in MS Excel, MS Word, MS Outlook, MS Visio, MS Project, Adobe Acrobat are vital.
- Bachelor's degree in Life Sciences, or equivalent experience, is essential Experience in the pharmaceutical industry . Working knowledge of drug laws, regulations and guidelines is essential. Working knowledge of Records Management in GxP/GCP environment.
Sthree US is acting as an Employment Business in relation to this vacancy.