Director, R&D Records Management

I. Position Summary:

This position is responsible for leading Biogen Idecs R&D Records Management (REM) Team, which reports into Regulatory Operations. Responsibilities include directing all efforts around Trial Master File (TMF), more specifically the implementation of the new BIIB e-TMF and the processes that will support it. This position will be responsible for creating and leading the training, education, and compliance aspects of the e- TMF system roll out. This position will be a key leader in Biogen Idecs transition to a fully electronic TMF.

This role will lead the transformation of the current group to be a more strategic function.

II. Duties and Responsibilities:

A. Essential Functions:

- Lead the implementation, operation of e-TMF, and related tasks such as training and compliance.
- Provide leadership and development of the Records Management Team. Lead the creation of a vision and strategic plan for the organization
- Build and maintain excellent relationships with relevant R&D functions, vendors, and corporate Records Functions.
- Monitor new eTMF vendor operations and service level
- Develop and lead continuous improvement opportunities initiatives
- Lead expansion efforts of REM beyond Clin Ops, coordinating a well-integrated Records Management approach within R&D.
- Develop TMF monitoring plan based on document / artifact risk
- Provide leadership on project teams and subcommittees.
- Ensures appropriate REM representation on project teams.
Ideal candidate will have a minimum of 10 years in industry, 5 years strategic records management leadership, project and planning experience, including experience with TMF, and 5 years people management experience. Good knowledge of applicable rules & regulations (GCP).

- Well experienced in Trail Master file (TMF), specifically e-TMF, and Clinical Operations processes.

- Ability to lead and influence project teams, committees, etc. to attain group goals.

- Demonstrate excellent leadership and communication skills.

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- Demonstrate strong organizational skills, including the ability to prioritize personal workload.

- Strong interpersonal skills and the ability to effectively celebrate with all levels across the organization including medical, scientific, and manufacturing staff.

- Experience leading multi-disciplinary / remote teams.

- Well organized, detail oriented, effective written and oral communication skills.

- Ability to guide, train, supervise, and prioritize workload of direct reports.