Regulatory Compliance Specialist

2 weeks ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Description

This is a supervisory position that requires effective leadership and communication skills to manage a team and ensure the efficient upload and management of electronic documents in the eTMF system.

The successful candidate will be responsible for managing a team of eTMF Specialists, allocating workload, overseeing quality reviews, training and developing team members, and prioritizing the book of work.

The ideal candidate will have a strong background in regulatory compliance and clinical trial documentation, with experience in directly managing, leading, and developing employees.

They will also possess comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management, as well as extensive knowledge and application of ALCOA Plus standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (ICH-E6).

The successful candidate will be able to interact and communicate effectively at all levels of the organization, with strong leadership and people management skills.

They will also be able to prioritize work and assess risk to meet the needs of the organization, and be adaptable and able to modify personal and organizational work style to meet the needs of the business.



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