Senior, Medical Advisor

5-6 years

Not Disclosed

Mumbai

10 July 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position: Medical Affairs Lead - Oncology

Location: Pfizer India

Primary Responsibilities:

Internal Stakeholder Collaboration:

Partner with internal stakeholders such as marketing, sales, regulatory, medical information, drug safety, clinical development, legal, compliance, and other medical affairs teams.
Develop, lead, and execute integrated medical plans in alignment with commercial objectives for the allocated Oncology portfolio.

Medical Affairs Strategic Planning:

Collaborate with the country commercial team to develop and execute medical affairs strategic plans for Oncology products.
Ensure new product launches are on time and compliant with internal and external regulations.

Team Development:

Work closely with the Medical Lead Oncology to mentor and develop the Oncology Medical team members.

Global and Regional Collaboration:

Collaborate with regional and global medical affairs teams to understand global medical strategies and implement best practices locally.

External Stakeholder Engagement:

Engage with key external stakeholders, including key opinion leaders, patient associations, physician associations, and regulatory bodies, for customer insights, advocacy, and relationship building.
Ensure alignment with Pfizer policies and local regulations.

Scientific Congress Participation:

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

Research and Publication Oversight:

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

Promotional Strategy:

Lead the conceptualization and medical review of all promotional strategies for the portfolio to ensure scientific accuracy and compliance with Pfizer policies and local regulations.

Budget and Resource Planning:

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

Compliance:

Ensure compliance with all local policies, procedures, and regulations for self and team in all activities relevant to the allocated Oncology products.

Strategic/Policy Responsibilities:

Provide tactical and strategic inputs to Product Management for the ethical promotion of assigned products.
Create medical strategies aligned with commercial BU strategies, global medical strategies, local business goals, and local customer insights.

Operational Responsibilities:

Commercialization and Promotion:

Provide strategic inputs for marketing/brand plans, medical development plans, and medical-marketing programs.
Initiate, review, and approve promotional, training, and Continuing Medical Education (CME) material.
Participate in and facilitate educational interactions with Health Care Professionals (HCPs).

Clinical Research:

Develop and review protocol synopses, final protocols, and supporting documents for clinical projects.
Collaborate with Study Management to provide training on clinical research methodology.
Assist in planning and preparing Investigational New Drug Applications (NDAs).
Review and interpret data generated from studies and write final reports.
Develop and execute publication plans and write manuscripts for publication.

New Product Planning/Development:

Assist with preparing business cases and pre-commercialization programs for global products.
Support marketing and business development with medical evaluations and recommendations for new products.
Support local formulation development through literature search and internal approvals.

Regulatory:

Provide medical and product expertise for new product registrations and defense of marketed products.
Write, revise, and review labeling documents.
Support processing of adverse event reports.

Medical Information:

Provide timely, accurate, and balanced medical information to internal and external customers.

Sales Force Training:

Provide medical training to new and existing sales staff on basic sciences, therapeutic areas, and products.
Conduct pre-launch and launch training for new products.

Required Skill Set:

Qualifications & Experience:

MD required with 5-6 years of progressive experience in Pharma or allied industry (medical affairs and clinical development). Oncology experience preferred.
Demonstrated experience in leading and executing medical affairs strategies.
Proven ability to build strong relationships with key stakeholders.
Experience leading innovative medical affairs projects.
Strong strategic mindset and familiarity with local health policies, codes, and regulations.

Special Skills & Knowledge:

Knowledge of therapeutic segments and related medical information.
Understanding of regulatory aspects related to the pharmaceutical industry.
Knowledge of Pfizer policies and procedures, including promotional practices and adverse event reporting.

Equal Opportunity Employer:

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

This structured format covers all the key aspects of the job description in a clear and organized manner.