Team Lead- Medical Affairs

We are looking for experienced and dynamic Team Lead in Medical Affair for Oncology to actively contribute to the organization/business by taking people managerial responsibility and being responsible for the scientific, technical and ethical soundness of all policies, statements and endeavours. He/she will need to provide high quality and timely service in the areas of product commercialization/promotional support, interactions with healthcare professionals, continuing medical education, clinical research, sales force training, medical information, and performance/people management, and business support in the areas of new product development, regulatory affairs, quality standards, and information technology; alliance management may be included as applicable.

Roles & Responsibilities

You will be responsible to provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed

You will be responsible for providing strategic inputs for marketing and brand plans, overseeing the design and execution of medical-marketing programs, and facilitating interactions with healthcare professionals. Additionally, you will initiate, review, and approve promotional and educational materials while ensuring compliance with relevant SOPs, regulations, and industry codes.

You will be responsible for developing, reviewing, and approving protocol documents and supporting materials for various clinical projects. Additionally, you will collaborate with Global Medical Affairs and Clinical Development, organize training sessions for project teams, and provide medical support for safety reporting and ongoing local studies. Furthermore, you will contribute to the planning and execution of Investigational New Drug Applications (NDAs).

You will be responsible to provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external customers.

You will be responsible for training the Sales Force on basic sciences/assigned products and pre-launch and launch training for new products.

You will assist the New Product Planning team in preparing business cases and pre-commercialization programs for global products, development of local formulations and line extensions. Additionally, you will provide support in market research, stakeholder mapping, and early access programs. You will also collaborate with various departments to evaluate commercial opportunities, including licensing, acquisitions, and co-promotion.

You will be responsible for providing medical and product expertise in the registration of new products/indications, as well as defending marketed products to various stakeholders. You will also oversee the writing and review of labelling documents and provide medical support for the processing of adverse event reports, adhering to relevant SOPs and practices.

You will be responsible to develop and share expertise in identified medical and/or scientific therapeutic area, including but not limited to disease areas, markets, products (DRL products and key competitors) and services.

You will be responsible to develop and share expertise in a specific medical/scientific subject, including protocol design, development, and training, Pharma co economics, Outcomes Research, Health Technology Assessment, New Product Evaluation, Disease Management Programs, Intellectual Property Protection and Patents, and Medical Information

You will be one-point Medical Affairs contact for Customer Relationship Management and operational liaison in the various functional domain.

You will be responsible for fostering a culture of learning and development and managing the Medical Affairs staff, providing training, guidance, and support across various functional domains, ensuring adherence to company values and behaviours, and.

You will be responsible to support cluster Head Medical Affairs in budgeting, provisioning and expense control.

Qualifications

Educational Qualification-

Minimum work experience

Skills & attributes

Technical Skills

Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines

Knowledge of pharmaceutical medicine including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics and relevant Therapeutic Area/Products

Expertise in clinical trial design and methodology, and understanding of interfaces, and conduct

Behavioural Skills

Communication skills, both written and verbal (including medical writing and presentation skills)

Analytical skills and reasoning, and sound medical judgment/decision making

Interpersonal skills, internal & external networking and the ability to impact and influence.