Vacancy: Ass. Director – TMF (Biogen Idec)

 

This position is responsible for managing overall Trial Master File (TMF) operations including third party vendors and TMF systems. Act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, etc.). He/She provides oversight of external TMF Document Specialists and ensures that all documentation activities are conducted in compliance with regulatory requirements. He/She is responsible for overseeing internal systems used for TMF records, and reviewing document quality audit outputs to identify trends across the portfolio to ensure quality documentation. He/She identifies root cause of performance issues, determines the appropriate remediation, and escalates issues with performance when required.

I. Duties and Responsibilities:

A. Essential Functions:

• Manage overall TMF operations and third party vendors, and act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor.
• Manage and provide direction to external TMF Document Specialists and ensure that all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards.
• Manage and provided direction for internal and external systems used for TMF records. Work with stakeholders to identify issues and remediation activities with vendors.
• Review document quality audit outputs to identify trends across the portfolio to ensure quality documentation.
• Identify root cause of performance issues, determine the appropriate remediation, and escalate issues with performance when required.
• Prepare and deliver effective presentations for external and internal audiences.
• Represent Biogen to external vendors

B. Additional Functions:

• Contribute to organizational effectiveness.
• Effectively serve as a role model within regulatory and cross-functionally.
• Positively impact industry and agency organizations.

Qualifications
• 9 years pharmaceutical/biotechnology industry experience. Relevant clinical, regulatory and TMF systems experience preferred.
• Solid knowledge of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Foster effective, positive interactions with other functions, vendors, and partners.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate excellent leadership and communication skills.
• Ability to represent the department in project teams, committees and external meetings.
• Demonstrate strong organizational and project management skills, including the ability to prioritize personal workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical and scientific staff.
• Well organized, detail oriented, effective written and oral communication skills.
• Ability to influence without authority.
Education
Bachelor’s degree required, Masters or PhD in Biology / Chemistry, Life Sciences, or Drug Development preferred.
Contact: m a t t . s o l o p e r t o @ b i o g e n . c o m
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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
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