• Responsible for completing substantive reviews and overseeing the operational elements associated with databases and archives for key compliance activities including, but not limited to, healthcare professional engagements, grants and donations, sponsorships, and displays and exhibits.
• Provide day-to-day operational compliance guidance to employees in functions including, but not limited to, Sales, Marketing, Market Access, Global Medical Affairs and corporate functions supporting the GOBU
• Identify and analyze trends, produce statistical reports to support the development of discussions and presentations with GOBU Compliance management.
• Collaborate with other members of the OBU Compliance team, both proactively and on an as-needed basis, for project-based and operational activities pertaining to various elements of Takeda’s ethics and compliance program.
• Coordinate cross functional project teams in support of compliance projects and ensure said projects are timely completed.
• Support compliance monitoring activities and investigations into potential compliance matters as needed in collaboration with compliance colleagues.
• Participate in global compliance initiatives as needed.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Bachelor’s Degree required
• 3+ years of relevant pharmaceutical, healthcare, agency, legal, paralegal and/or professional experience required
• Experience in healthcare or the pharmaceutical industry desired.
• Experience in ethics and compliance programs desired.
• Working knowledge of regulatory requirements pertaining to pharmaceutical industry, including OIG regulatory guidance, PhRMA, and FDA regulations also preferred.
• Effective oral and written communication skills required. Require proven ability to work successfully, both independently and with others, and to collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.
• Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required
• Must have computer proficiency and able to utilize MS Office software (e.g., MS Word, MS PowerPoint, MS Excel) at an advanced level. Microsoft SharePoint and Salesforce platform experience required
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.