Cluster Medical Lead- Singapore/malaysia/brunei

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.

**Overview**:
As the Cluster/Country Medical Lead (CML) you will be the Medical Leader in your market and serve as the leader of the medical affairs organization in your geography. Reporting to the Cluster Medical Director of South East Asia (SEA) Cluster you will be the primary market level contact for Medical Affairs.

**Key responsibilities**:

- Coordinate, Develop and execute the Medical Affairs (MA) strategy for the country.
- Create and maintain a high-performing, highly compliant MA organization for the market.
- Manage the entire portfolio for the company, allocate resources balancing global and local priorities.
- Represent Medical Affairs in the Country Leadership Team; and in cross-functional collaborations with other functions, Human Health (HH) and others.
- Communicate, accomplish, opportunities, and needs of the country to regional and global stakeholders.
- Represents company in external activities requiring the leadership and expertise of the Senior Medical Leader.

**What will you do**:
**Leadership and Management of the Medical Affairs Organization**:
**People**:

- Lead in a matrix organization thru shared leadership with TA Leads, Medical Advisers based in the market.
- Proactively identify new opportunities and also gaps vs emerging needs and address in a timely manner by reallocating and training of existing staff and external recruitment.
- Create an empowering, compliant, collaborative, and innovation-focused work-environment.
- Build a culture of quality and compliance through training, oversight, and collaboration.

**Country Medical Affairs Plans (CMAPs)**:

- Coordinate the development and execution of CMAPs, including tactical deliverables for each of the therapeutic areas, such as post-licensure research, publication plans, investigator
- initiated studies, and other knowledge transfer activities;
- Ensure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs);
- Coordinate the country developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local and manage their execution.

**Medical Affairs Management**:

- Manage approved operating administrative (e.g. salaries & travel) and life cycle management budget (e.g. Advisory boards, Local Data Generation etc.);
- Oversee inspections and inspection audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, PV and Global Clinical Trial Operations (GCTO).

**Collaboration with Key Internal Stakeholders**:
The CML represents Medical Affairs in cross-functional leadership teams and collaborations, and advocates for the interests of the market (or cluster) with regional and global colleagues.

**Global Clinical Trial Operations (GCTO), Global Clinical Scientific Affairs (GCSA) and Pharmacovigilance (PV)**:

- Support for GCTO when requested.
- Manage the submission and role in the conduct of Investigator-Initiated Studies;
- Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitate Chief Medical Officer (CMO) approval of these requests.
- Support to the Local QPPV as medical qualified person.

**Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH and Policy**:

- Interact with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies;
- Collaborate with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for company's entire portfolio of medicines and vaccines.
- Provide medical expertise to the commercial product teams, ensuring the scientific and medical value of products across all therapy areas.

**Engagement with Key External Stakeholders**:
The CML represents company as an executive leader and scientific expert to the external community.
- Serve as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions and the broader scientific community to lead and execute the medical research and implementation strategy for innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs
- Collaborate with CORE, Market Access, and Commercial colleagues to engage payers, policymakers, and othe