Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary:
The Senior Study Associate, Office of Medical Access, Global Oncology Medical Affairs (GOMA) plays a pivotal role in supporting the planning, execution, and oversight of the Medical Access Programs. Working under the guidance of Director, Office of Medical Access, the Senior Study Associate, Office of Medical Access, GOMA ensures that Medical Access Programs are conducted in compliance with regulatory standards, protocols, and timelines. The role involves interacting with CROs and other vendors, providing administrative support for the Office of Medical Access as well as tracking metrics and enrollment in the various programs used in the Office of Medical Access.
Responsibilities:
- Assist in the planning and execution of Medical Access Programs (MAPs) under the close supervision of the Associate Director (or above) within the Office of Medical Access, GOMA, Good Clinical Practices (GCPs), MAP Standard Operating Procedures (SOPs), and Health Authority regulations.
- Provide program related administrative support to the Office of Medical Access (OMA). This may include preparing and distributing meeting logistics, agendas, and minutes for OMA team meetings, including meetings with vendors.
- Interacting with the Contract Research Organizations (CROs) and other vendors conducting/supporting the MAP to ensure compliance with Daiichi Sankyo (DS)SOPs.
- Collect information and coordinate with DS Trial Disclosure Office to post program information on required public forums (e.g., clinicaltrials.gov), if applicable.
- Track MAP metrics such as site enrollment, drug requests, etc. by maintaining applicable databases (i.e., Veeva, Accelerate, Microsite, CTMS), and/or creating and maintaining spreadsheets to track other items as needed.
- Support, and assist the transmittal of program specific documents in support of the Trial Master File (TMF), as applicable. Reconcile the TMF document trackers generated by the CRO with the document archive.
- Support the review and drafting of MAP documents such as guidance documents, etc.
- Manage the submission of documents to GCSRC for review and approval according to the appropriate process and utilizing the assigned system in place.
- Manage the overall execution of the programs to ensure timely review and completion of documents as well as shipment of medication for programs that are being managed in-house
- Manage the MAP mailbox daily and triage emails as required as well as the OMA SharePoint to ensure final documents are uploaded in a timely manner.
- Manage the update and review of the MAP microsite to ensure that rules for responding to inquiries from HCPs are accurate.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree required Experience Qualifications
- 2 or More Years overall related experience required
- 4 or More Years related experience preferred
- Pharma or CRO experience preferred
Travel
Ability to travel up to 10%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
$86,160.00 - $129,240.00