Senior Manager Medical Affairs

Primary Responsibilities

Partner closely with internal stakeholders such as commercial (marketing and sales), regulatory, Medical Information, Drug safety, Clinical development, legal, compliance and other BU medical affairs teams to develop, lead and execute an integrated set of medical plans in alignment with commercial for supporting the allocated Oncology portfolio at Pfizer India:

Work collaboratively with the country commercial team to develop, lead and execute the medical affairs strategic plan for the allocated Oncology products.

Work closely with internal stakeholders like regulatory, clinical development to ensure new product launches on time and in compliance with internal and external regulations

Work closely with the Medical Lead Oncology for mentorship and development of the Oncology Medical team members

Collaborate with the regional and global medical affairs team to understand the global medical strategies for the entire portfolio and bring in global best practices to build the local medical plans accordingly.

Actively engage with key external stakeholders such as Key opinion leaders, patient associations, physician associations and regulatory bodies for customer insights, advocacy and relationship building for the allocated Oncology portfolio in alignment with Pfizer policies and local regulations.

Ensure participation in key scientific congresses by self or team to disseminate or gather relevant scientific information for the portfolio.

Review and approve the research proposals (ISRs), grant proposals, publication plan and other medical projects for the assigned portfolio in alignment with the overall commercial strategy.

Lead the conceptualization and medical review of all promotional strategies for the portfolio to ensure they are fair balanced, backed with scientific data and in accordance with Pfizer policies and local regulations.

Plan and execute the medical affairs budget allocated for the assigned portfolio and ensure appropriate resource planning for all key brands / projects of the portfolio.

Be ultimately accountable for complying to all local policies, procedures and regulations for self and team in all activities relevant to the allocated oncology products.

Strategic/Policy

Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed

Create medical strategies aligned with the commercial BU strategies, global medical strategies, local business goals and local customer insights

Operational

Commercialization/Promotion of Allocated Portfolio (New/Key Detail/In-line Products)

Provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines

Initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices

Participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc. 

Clinical Research

In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e.g., investigators’ brochure (IB), informed consent form (ICF), patient information sheets, etc) for , Phase IV, PMS, Observational studies / surveys, Pharmacoeconomic / Outcomes Research studies, and other clinical projects / programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc

Collaborate with Study Management in providing training to in-house project teams (CRAs, project secretaries/assistants) and site project teams on clinical research methodology, study design, protocol/CRFs through on-site coaching/training sessions/workshops for local studies

Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs)

Review/interpret data generated; write final reports for locally sponsored studies as required

Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies

Develop and execute Information Dissemination Plan/Program

New Product Planning/Development

For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to “prepare” internal and external stakeholders for commercialization. These include assistance with market research, stakeholder mapping, and early access programs

Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products (e.g., licensing, acquiring, co-promotion, etc.)

Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process

Regulatory

Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.

Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)

Write, revise, and review labeling documents for pipeline/local products per relevant SOPs

Provide medical support towards processing of spontaneous/solicited AE reports, per relevant SOPs and/or working practices

Medical Information

Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies

Sales Force Training

Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives

Provide pre-launch and launch training to sales staff for new products

REQUIRED SKILL SET

Qualification & Experience

MD required with 5 - 6 of progressive experience in Pharma or allied industry (medical affairs and clinical development). Experience in Oncology preferred.

Demonstrated experience in leading and executing medical affairs strategy in multiple therapeutic areas.

Demonstrated ability to successfully build strong relationships with key stakeholders.

Demonstration of leading innovative medical affairs projects in one or more TA.

Very strong communications and relationship building capacity with internal and external stakeholders.

Strong strategic mindset, familiarity with building a strong medical strategy plan, local health policies, codes and regulation.

Special Skills & Knowledge

Knowledge of therapeutic segments and related medical information.

Knowledge of regulatory aspects and issues related to the pharmaceutical industry.

Knowledge of applicable Pfizer policies and procedures, including those relating to promotional practices and adverse event reporting.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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