Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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
Drive medical and operational compliance standards as the Center of Excellence (CoE) lead for the business implementation across all key Global Oncology Medical Affairs (GOMA) activities, in close collaboration with cross-functional and regional stakeholders. Develop and ensure execution of an effective and efficient GOMA CoE Risk Management Plan (RMP) and support conduct oversight. Assess CoE compliance risks and operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across functions, geographies and levels of the organization.
Responsibilities
- CoE Risk Management Plan (RMP) and operational oversight:
In partnership with QA and other relevant stakeholders across line functions, geographies and levels of the organization, establish a systemic GOMA CoE RMP process to identify, evaluate, prioritize, mitigate and monitor risks and support
Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized GOMA CoE process
Prepare and facilitate regular GOMA CoE meetings to ensure appropriate communication, involvement, resource assignment negotiation and buy-in with relevant stakeholders
Help drive the operational execution of the GOMA CoE RMP process and proactively manage the resource model and timelines
- Support CoE Audit Inspection Plan:
Manage and establish a GOMA CoE Audit Inspection Plan in partnership with QA and relevant stakeholders across functions, geographies and levels of the organization
Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized process
Prepare and facilitate regular GOMA CoE meetings to ensure appropriate communication, involvement, and buy-in with relevant stakeholders
Ensure and oversee strong remediation plans for CoE findings and incorporate into the GOMA CoE RMP
Lead and/or direct activities to support GOMA CoE team during preparation, conduct and closure of in partnership with relevant stakeholders
- Governance Operational Excellence
Contribute to the development and support with operational execution of a sustainable document Life Cycle Management (LCM) process for proposing, developing, reviewing, approving, training, distributing and archiving of global procedural documents for Medical Affairs (MA) activities, as applicable
Support the GOMA CoE process for assignment and tracking of required and supplemental trainings in the Learning Management System (LMS)Establish maintain effective communication channels to raise awareness of GOMA CoE compliance-related matters across MA
Coach or mentor team members
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 in Science, Pharmacy, Medicines or Business Administration required
Experience Qualifications
- 10 or More Years of experience in pharma at local, regional and/or global level preferred
- Excellent verbal and written communication skills required
- Strong knowledge on operational aspects of medical affairs activities preferred
- Knowledge and/or experience in leading medical affairs oversight & governance activities preferred
- Awareness of external trends and changes in regulation in order to proactively adjust internal processes preferred
- Ability to facilitate and influence decision making to drive results required
- Proven ability to drive pragmatic solutions to complex problems required
- Strong change management skills to drive and sustain a culture of high ethical standards and compliance required
- Ability to foster an environment of trust which encourages associates to proactively bring forward issues and seek guidance required
- Considerable organizational awareness, including experience working across functions and geographies to achieve high performance required
- Display enterprise leadership by building strong internal and external relationships with diverse stakeholders that maximize alignment and organizational effectiveness required
- Expertly manage ambiguous and highly complex situations required
- Effectively manage oversight of different and diverse activities (clinical program, publication, medical education, Advisory boards) preferred
- Ability to integrate subject matter expertise and cross-functional perspectives to ensure that proposed solutions effectively meet the needs of all stakeholders required
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.