Director, Medical Affairs

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.

**Role Overview**:
The Cluster Medical Director is the Senior Medical Leader for the SEA Cluster comprising of Singapore, Malaysia and Hong Kong. (S)he will be the primary cluster level contact for medical affairs. (S)he is responsible for:

- Oversight of the development and execution of the Medical Affairs (MA) strategy for the cluster, based on understanding of global, regional and cluster opportunities and requirements;
- Creating and maintaining a high performing, highly compliant MA organization for the cluster;
- Representing cluster opportunities, requirements and needs at the regional and/or global levels, as appropriate; Representing medical affairs in the Cluster Leadership Team; representing the company in external activities requiring the presence of the cluster’s Senior Medical Leader;
- Coordinating with the cluster GCTO, Pharmacovigilance, RA and OR, BARDS staff to ensure well-functioning interactions between the company and external in-country stakeholders
- Managing the entire portfolio for our company, allocating resources balancing global and cluster priorities. (S)he builds on existing capabilities through internal development and external hiring, analyzes and fills gaps by reallocating resources and creates an empowering, compliant, collaborative, and innovation-focused work environment.
- Managing the medical aspects of submissions for reimbursement or tenders for the entire portfolio of medicines and vaccines (collaboration with OR, BARDS, market access, and commercial colleagues).

As part of the Leadership of V&I (Value & Implementation), the Cluster Medical Director will assist in maintaining GMSA as a leading research-based MA organization. As such (s)he will help create and execute a strategy for the future evolution of GMSA building on existing strengths while identifying key areas for improvement and implementing plans to address these elements.

**What will you do**:
The Medical Director is responsible for oversight of all aspects of Cluster Medical Affairs (MA), including:

- Cluster MA team focus on cluster MA strategy, with a heavy emphasis on helping to develop global MA strategy, support of strategic planning for medical support of Company objectives.
- Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities.
- Strategic planning and support of Company interactions with Authorities and relevant Organizations at all levels.
- Building of close relationships with regulatory, GCTO departments.
- Consulting Business Units on medical and scientific matters.
- Providing input into study feasibilities and sites in countries within the cluster, selection and implementing publication policy.
- Providing medical and scientific advice to business units, market access functions and others as required, as well as input into Health Economics. Also serving as a member of the respective country leadership teams. S/he may delegate the responsibility to a qualified in-country representative.
- Managing the developed Protocol Concept Sheets (PCS) and obtaining regional and global) approvals for new studies.
- Review and approval of study protocols and IISPs.
- Advising business units on medical and scientific matters, including—but not limited to—scientific approval of promotional materials.
- Ensuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local heads of regulatory.
- Overseeing all activities of Cluster Medical Department employees.
- Overseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and GCTO. S/he may delegate the responsibility to a qualified in-country representative.
- Enhancing the company reputation and profile through an external focus, by representing the company on cross-company boards and industry associations, represents the Company in mass-media (in collaboration with PR Manager).
- Orchestrate regional input for medical priority setting and co-sponsor the regional medical affairs planning teams to have bi-directional communication with HQ.

**Cluster Medical cross functional Management**:

- Successfully collaborating with the Affiliate/Cluster LT, Regulatory, Pharmacovigilance, Reputational (ie Public Relations), Legal, Compliance and other risk issues in the
- Leading Cluster Medical Governance Council ensuring that functional (Clinical, Regulatory, Safety and Medical Affairs) collaborate on planning and execution of clinical activities with a