Medical Operations & Governance Manager - Singapore
- To be responsible for coordinating Medical Affairs (MA) strategies & tactical activities / projects within the Asia Pacific (APAC) Area Medical Team and LOC Medical Affairs for all Therapeutic Areas (TAs) in collaboration with Area Director – Medical & Regulatory Affairs, Regulatory Heads & Therapy Heads within APAC Area Medical Team and LOC Medical Directors (MDs)
- To provide leadership for APAC Area for Medical Operations and Medical Excellence through governance in medical activities aligned to and integrated with the business and LOCs within APAC Area as well as EM Medical Affairs (EMMA). For Medical Operations, the position will work with key stakeholders in the creation, implementation, execution and governance of the overall medical plans and processes and will coordinate all operational efforts for MA sponsored studies and IISRs in the APAC Area.
- For Governance, the purpose of Quality Assurance in APAC MA is to ensure that all medical affairs activities are performed, documented and reported in compliance with company Research & Development – Quality Management System (R&D-QMS), Good Clinical Practice / Global Pharmacovigilance (GCP/GPV) international standards and local, regional, and international regulatory requirements.
- This is accomplished by providing effective and efficient support for APAC Area and LOCs quality assurance systems, oversight and counsel for all Medical Affairs functional areas.
- Wherever applicable, to be responsible for coordinating Quality Assurance (QA) & Regulatory Affairs (RA) strategies within the LOCs for all TAs in collaboration with EMMA and global functions
- Bachelor Degree in Pharmacology, Pharmacy, Biomedical Sciences or Advanced Degree preferred.
- Minimum of 10 years health care industry experience with a minimum of 5 years
- Medical Affairs or clinical development experience within the Pharmaceutical Industry.
Skills & Personal characteristics:
- Excellent leadership, managerial, interpersonal and relationship building skills
- Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure
- Excellent verbal and written communication skills in English, fluency in other languages is a plus
- Goal oriented, focused, energetic, and enthusiastic
- In depth knowledge of Medical Affairs disciplines and broad knowledge or other functional areas that interface with Medical Affairs, especially Medical Operations will be a plus
- Ability to think strategically across a portfolio of products in various life cycle stages
- Excellent organizational and problem-solving skills
- Understanding of the business, and the strategic impact health care trends have on business outcomes
- Experience with product strategy development and execution
- Thorough knowledge of regulatory requirements for Medical Affairs
- Familiar with regulations of new product development
- Experience in Medical Affairs activities
- Ability to work effectively in a cross-functional team environment
- Global mindset and demonstrated ability to collaborate and build strategic alignment across countries and/or regions
- Ability to effectively collaborate with internal and external stakeholders, customers and consultants
- Sound knowledge of medical compliance, QA, QMS, PV and GCP audits
- IT savvy and process orientated