Job Description

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Overview This position is in the Growth & Emerging Markets (GEM) region under Medical Affairs and reports to the GEM Medical Operations, Patient Access and Risk Management Head. The candidate will provide expertise and support on medical and R&D Quality Assurance (QA) to the country teams in the region, while collaborating with cross-functional stakeholders such as compliance, legal, the respective global organizations and vendors. Also, the candidate will be expected to develop, update, and maintain medical affairs document management and training systems as relevant matrices for the GEM region. Key Responsibilities

• Lead QA and governance for medical teams across GEM.
• Develop comprehensive regional and local plans in partnership with global QA and cross-functional stakeholders.
• Lead and provide guidance on country medical QA activities (including but not limited to medical affairs and GxP-regulated activities) by collaborating with regional and local level medical teams and cross-functional stakeholders.
• Lead review of existing medical processes and improvement for medical owned processes including global and cross-functional alignment.
• Ensure medical processes remain fit for purpose and value adding through continuous improvement like metric development, activities tracking and regular process reviews with stakeholders.
• Capability build and ensure country and regional medical teams are audit ready
• Drive development, review and approval of GEM medical affairs related SOPs and lead revision/updates as needed.
• Ensure QA gaps are identified and appropriately mitigated, support audits relevant to medical QA in the regional and local medical affairs office as appropriate.
• Lead corrective action/preventive action development as needed.
• Lead monitoring programs as deemed necessary.
• Responsible for internal training, tracking and reporting for regional oversight and management.

Qualification and Experience

• Minimum 5 years of experience in medical affairs, quality assurance or compliance in pharmaceutical industry.
• Experience in medical quality or governance at country or above country level preferred.
• Experience in medical governance process and procedural set ups and/or audit and formulation of CAPA plans preferred.
• Experience of collaborating with geographically disperse teams in a multicultural environment.
• Ability to partner with and influence stakeholders in a matrix organizational, quick to adapt to changing business needs.
• Excellent negotiation and communication skills.
• Highly organized, self-disciplined, and attentive to details
• Independent and self-driven with a positive work ethic
• Well versed in highly technical and scientific languages
• Fluent verbal and written English communication skills

Takeda is committed to employee\'s career development and our Talent Management teams may reach out to employees who previously indicated interest and readiness for such opportunities. We like to seek your understanding that we may not be able to consider every application for interview.

Locations

Singapore, Singapore

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time