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Job Description

Job Title:  Senior Medical Excellence & Governance Manager

Location:  TWN – Taipei

About the role: 

Responsible for coordinating the development and execution of Medical Affairs (MA) strategies & tactical activities within Medical Affairs for all Therapeutic Areas (TAs) in the country and collaboration with above country Medical Excellence and Governance

• For Medical Excellence, the position will work with key stakeholders in ensuring the creation, implementation, execution and governance of the overall field medical activities, external academic partnerships, brand medical plans and processes, including all operation efforts for launch readiness, and TA-agnostic medical projects
• For Governance, the purpose of Quality Assurance in local medical team 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 local quality assurance systems, oversight and counsel for all Medical Affairs functional areas.
• Wherever applicable, represent Medical Affairs involving coordination with Quality Assurance (QA) & Regulatory Affairs (RA) teams locally for all TAs in collaboration with above country functions.

How you will contribute: 

Overall

• Lead the Medical Operations function in country
• Ensure full execution of local MA strategic plans through close collaboration with MA colleagues above country level
• Drive the implementation, execution and adherence to the medical strategy & governance process and serves as a governance body for operational topics within MA
• Lead Medical Excellence strategy under the guidance and direction of country medical director and leadership team within country and in coordination with colleagues above country regarding Medical Excellence activities, such as External academic partnerships, Field medical interactions and Medical Communication initiatives
• Support local MA personnel in reporting of activity and tracking progress against goals of all MA activities. Ensure full transparency of MA activities and budget
• Develop, implement and promote quality initiatives within local Medical Affairs, foster continuous improvement of internal processes, through a monitoring program and systemic evaluations, and promote adherence to SOPs and regulations

Strengthen medical affairs capabilities to ensure quality input in planning processes and provide medical leadership

• Facilitate full implementation of Global, Regional & local Medical Strategy across TAs to meet overall organizational objectives
• Ensure that local medical strategy plans are in place and look for synergies
• Represent Country to align and collaborate with other Countries and above-country colleagues related to Medical Excellence initiatives
• Drive capability building of the medical team members within Country and contributes to the development of career path opportunities for Country medical affairs colleagues
• Advocate and develop visibility and appropriate resourcing guidance for the Medical Affairs teams within the Country
• Identify and coordinate training needs, including the provision of trainings, e.g. process, product, disease, QA, PV, etc.
• Assist Country Medical Affairs Director in ensuring that communication plans and channels are in place and functioning effectively

Create a robust system of medical compliance and ensure SOPs / code of conduct are strictly followed with no or minimal breaches

• Develop and implement Country Medical Affairs SOPs where required
• Implement Compliance Policies and Procedures in accordance with the Global Code of Conduct and aligning with Country Pharma Marketing practices and legal requirements
• Identify and manage the integration points and SOPs across functions to ensure alignment, minimize risk and eliminate duplication
• Lead Country input in developing global process documents (policies / SOPs / Working Procedure) and standards for companies MA community; this includes processes and standards for MA sponsored studies, IISRs, Publications, Medical Education, Advisory Boards, and Scientific Exchange, etc.
• Ensure all MA personnel in Country are adequately trained, and adhere to all applicable processes
• Align with Country and above-country operation teams’ QA stakeholders to define QA/audit needs for MA at the Country level, provide feedback on the audit approach, track progress / results of MA audits and support remediation activities for the Country.
• Lead the following QMS work streams for Country Medical Affairs where applicable:
  • Implementation and self-inspections of QMS systems in each Country
  • Support local PV and GCP activities as well as PV and GCP regulatory inspections and local records management
  • Local vendor management, including assessments / audits
  • Oversee and manage compliance to local GxP related agreements
  • Assist in QMS audits in Country (with regards Medical & Regulatory components), as needed with appropriate CAPAs, audit CAPA development and follow-up activities
  • Create audit tool package for Country to assist auditing vendors and train the vendor on the tools

Provide strong guidance for clinical research and diagnostic service activities

• Oversee MA sponsored diagnostic service programs in Country, ensuring budget numbers are aligned with operational execution, ensure timelines are met, contingency plans are executed where necessary and full governance is followed
• Collaborate with evidence generation colleague in Country to ensure full study-related governance is followed in Country

Strive forimpactfulmedical operation initiatives with greater emphasisonlaunch readiness

• Develop quality medical launch readiness processes to solidify medical affairs’ impact to the Country organization fulfilling PTRB
• Coordinate medical affairs operation that require alignment or collaboration between Country and above country, acting as a bridge in activities such as training, onboarding, performance measurement, etc. to facilitate cross-border participation or further meeting/event possibilities

Develop innovative external partnership strategies in alignment with long term Takeda R&D and commercialization strategy

• Engage external stakeholders to foster collaboration/partnership in alignment with country portfolio and pipeline strategies
• Champion Takeda innovative initiatives to enhance the scientific image and commitment to advance health care systems

What you bring to Takeda: 

•  At least Master Degree in Pharmacology, Pharmacy, Biomedical Sciences. Advanced Degree is (Ph.D. or M.D.) preferred
• Minimum of 5 years health care industry experience with a minimum of 3 years Medical Affairs or Clinical Operation experience within the Pharmaceutical industry
• Preferred Experience: Medical governance experience; Medical quality assurance experience; Expertise in developing strategic medical plans; Execution of academic partnerships externally; Clinical study execution experience; In-depth experience in pharmaceutical industry regulations
• Excellent leadership, managerial, interpersonal and relationship building skills
• Highly collaborative, confident and strong presence
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure
• Able to drive consensus across diverse stakeholders to achieve goals
• Ability to identify and proactively addresses issues before they reach crisis points
• Goal oriented, focused, energetic, and enthusiastic
• Passionate and committed in all undertakings
• Excellent verbal and written communication skills in English; fluency in other languages is a plus
• Excellent presentation skills
• IT savvy and process orientated
• Good knowledge of healthcare systems
• A high level of knowledge of regulatory environment including key regulatory agencies and approval processes relevant to the country

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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