MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
The Senior Trial Master File (TMF) Specialist is responsible for ensuring that MacroGenics studies have comprehensive and quality TMFs ready for audits and inspections according to MacroGenics processes. Support, consult, and coordinate with each study team for confirming the structure and plan for the TMF including but not limited to the set-up of the study structure in the eTMF, study team assignments within the eTMF, confirm QC content is completed according to plan, and oversee closure and final archive of the study eTMFs. Act as the eTMF system SME and administrator.
Responsibilities and Job Duties
Education and Experience
Knowledge, Skills and Abilities
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