Merck Group - Associate Medical Director - Medical Head - CH-India

The Associate Medical Director, Head of Medical - CH India has overall accountability for Medical Management including discretionary and non-discretionary activities relating to the consumer health brands (Legacy and Primary Care) relevant to India and cluster markets (Sri Lanka, Nepal and Mauritius).

The Head of Medical - CH India will represent Medical Management in the India Business Operation Leadership Team (iBOLT) with accountability for delivering high quality strategic leadership, scientific/ medical input and to elaborate, compile and to oversee the delivery of agreed medical-scientific objectives to support delivery of India and Cluster business objectives.

The Head of Medical-CH India will have overall budget accountability for both activation and operational cost related to the local India business.

The Head of Medical-CH India has overall accountability for implementation of a Medical Governance framework in India and India Cluster markets to ensure compliance with internal CH policies, external regulatory and legal obligations.

They are accountable to provide medical leadership to the local medical management team with the aim of delivering high quality strategic scientific/ medical input and to elaborate, compile and to oversee the delivery of agreed medical-scientific objectives in line with expectations.

The Associate Medical Director role is also directly accountable for leading medical activities relating to the Legacy portfolio of brands including but not limited to Neurobion, Nasivion, Seven Seas and Dvion.

The following tasks may arise from the following areas but are not limited too:

Strategic Marketing / Export / Business Development / BUs:

- To provide medical scientific input to appropriate brand equity development, messaging and strategic direction

- To act as a scientific/ medical advisor within iBOLT for CH related matters

- To provide information/recommendation in terms of scientific questions (e.g. market researches, requests / product offerings by third parties and BUs).

- To approve promotional and non-promotional materials (claims, scientific content of materials developed locally e.g. packaging, SmPC, PIL, folder, press releases, TV copies, advertisement for all brands as required and in line with local review and approval process

- To lead development of Medical Activities plans for Legacy portfolio in alignment with overall business strategic plans. - To provide oversight to the Medical Activities plans for Primary Care Portfolio

- To contribute to the development of marketing and sales materials for legacy brands

- To provide scientific input and expertise in the design and construction of promotional material

- Scientific trainings/ materials - to develop, prepare and to maintain internal and external scientific trainings and to present the data accordingly

Opinion Leaders (KoLs, Medical Experts & Patient organizations):

- Overall leadership for KoL management in India and cluster markets.

- To provide oversight of activities relating to Legacy brands with involvement of Medical Experts (according to the Company's Compliance requirements): to establish & maintain contacts to Medical Experts, to lead scientific advice meetings, to prepare or to approve publications, presentations or scientific papers; to cooperate with HCP-related organizations.

- Scientific trainings/ materials - to develop, prepare and to maintain internal and external scientific trainings and to present the data accordingly.

Innovation:

- To lead and enable medical-scientific assessments and to provide recommendations on NPDs, ROs and claims innovations for India and cluster markets

Company Core Documents:

- Medicinal products: To oversee and enable scientific support in the process of implementation of the Company Core Data Sheets (e.g. reply to authority's requests, provide clinical expert statements). For Legacy brands lead development and to maintain the non-clinical and clinical part of local dossiers in line with local and corporate regulations/ policies.

- Food supplements: To oversee and enable development and maintain local PIs (Product Information; labelling relevant) and the SI (Scientific Information)

Life Cycle Management / Regulatory authorities:

- To ensure that current scientific knowledge is adequately reflected in the scientific documents intended for local regulatory purposes.

- To coordinate scientific requests issued by authorities and to provide the requested data/information accordingly, provide expert statements as required.

- To ensure provision of scientific data to BUs in terms of scientific questions.

Clinical studies / non-interventional studies & publications:

- To support the set-up of all studies conducted in India or India cluster markets whether Merck or Investigator-sponsored (in close cooperation with Clinical Development), to review the study report and to create and/or manage scientific publications, where required with external Medical Experts

Medical Governance/ Medical Information/ Product Safety:

- Field responses to external Medical Information enquiries originating from with cluster markets in line with internal and external systems/ policies/ regulations

- To perform the clinical evaluation in the course of the preparation of a Periodic Safety Update Report (PSUR).

- Lead development and enable implementation of Medical Governance training within India and Cluster Markets