Medical Affairs Expanded Access Manager

Waltham, MA

Posted: 09/11/2019 Employment Type: Contract Industry: Life Sciences Job Number: 230419

Medical Affairs Expanded Access Manager



 



Position Description



The Expanded Access Manager for Medical Affairs manages the operational components of Client’ s Oncology early access/compassionate use programs.  The EAP manager works closely with Medical Affairs teams to operationalize individual patient programs and/or EAP programs.  Responsibilities include processes from initial study request through study close out,  including internal review and approval, initial budget assessment, as well as the tracking, close-out, and archival of documentation for approved studies.



Applicants should understand oncology research and a desire to expand upon their knowledge of GSK pipeline products across multiple disease indications.  They should have prior experience with clinical research or expanded access programs  in a study manager or CRA role. 



The Clinical Research Manager will be responsible for establishing strong partnerships with internal and external teams.



 



Responsibilities



·        Provide coordination support for the EAP including status tracking, IP management, safety reporting, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice. 



·        Management of vendors to support EAP execution ·



·        Lead and co-ordinate the development and management of EAP protocol regulatory document collection, timelines and metrics; ensures timely and quality deliverables;



·        Provides status update reports on program usage



·         In partnering with Tech Ops, lead planning, forecasting and management of clinical supply (IP)



·        Monitors vendor shipments and endures inventory at both the depot and site level ·



 



  Abilities



·        Proven success working in a team setting and contributing to team success.



·        Proven ability to work with a high level of integrity, accuracy, and attention to detail.



·        Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.



·        Strong technical/analytical skills to identify and solve problems.



·        Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.



·        Is comfortable with ambiguity and can make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.



·        Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.



·        Flexible, resourceful, creative, enthusiastic, and results oriented.



·        Enjoys working in a fast-paced environment.



 



 



Job Requirements



 



·        BS/MS degree with 2-3 years of progressive experience in oncology Medical Affairs and/or Clinical Operations (background in life sciences preferred).



·        Oncology clinical experience very much desired



·        Experience working in clinical research or EAP program



·        Demonstrated knowledge of protocol design in oncology studies.



·        Thorough knowledge of FDA, ICH, GCP, and OIG guidelines.


  • Understanding of cross-functional clinical processes including biostatistics, medical writing, drug safety, regulatory affairs, legal, clinical supply, medical affairs and scientific R&D.
  • Strong planning and project management skills.

 

 



 

 
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