Team Lead Medical Affairs

Job Purpose
Generate and provide scientific know-how in designing promotional strategies, supporting sales force development, assisting with portfolio selection, regulatory, pharmacovigilance, compliance/ethics, and other scientific communications, in order to shape the assigned therapy(s) in an ethical and medically accurate approach.

Key Accountabilities
Accountability Cluster Major Activities / Tasks
I. Achieve scientific proficiency to drive the development of assigned therapy areas in
accordance with the medical strategy
II. Ideate and conceptualize with marketing team to develop promotional strategies to
drive India and international business
III. Identify therapeutic gaps in the product portfolio and suggest new molecules/
formulations/ incremental innovations in order to contribute towards building a robust
therapy-product mix
IV. Build team capability by conducting training sessions and guiding team members on how
to develop their competence
V. Build external advisor relationship to help steer the therapy market
VI. Ensure ethical actions by adhering to regulations and laws • Keep abreast with the latest medical developments through publications, websites and by attending national & international
conferences
• Understand on ground clinical practices by interacting with clinicians, to develop practical knowledge and utilize it to provide closer-to-market product solutions
• Create scientific publications on key therapeutic areas for the Cipla Library and external publishing
• Identify the need, plan for, and select faculty, for organizing advisory boards, RTDs, CMEs, symposia, webcasts, conferences etc., working closely with the Therapy Group Lead
• Create and curate scientific content and promotional material (such as newsletters, scientific booklets etc.) for online and offline usage by the marketing team during campaigns
• Review medical literature created by reporting team members• Create medical material to support new product launches
• Share latest product and therapy developments in the market, with the marketing team via reports
• Drive and conduct post-marketing surveys with doctors and other allied stakeholders for the allocated therapy areas
• Develop medical content to support patient engagement for the product
• Provide medical resources (such as product brochures) to equip the field force with accurate content to tackle doctor queries
• Identify, analyse and recommend new molecules, devices and products for the domestic and global business, by studying market trends
• Provide a medical opinion and rationale to assist the portfolio, API and in-licensing teams in selecting the appropriate portfolio mix
• Analyse and recommend incremental enhancements in the management of product lifecycles, in line with the changing treatment paradigms and new developments in therapy
• Develop protocols for research projects in liaison with clinical trials department and get approval from group lead
• Develop content and material for medical trainings of internal team and sales team
• Develop induction training program with content for new team
members
• Track effectiveness of trainings regularly by means of feedback from the team as well as ROI achieved from them
• Identify new KOLs and initiate contact with them
• Engage existing and new KOLs through various scientific activities
• Leverage KOLs and therapy consultants for strategy development, training and understanding therapy landscape as well as for potential hiring
• Ensure compliance and adhere to internal policies, local and international regulations for scientific, promotional materials, activities and therapy/ product related queries from internal and
external stakeholders
• Prepare, review and update package inserts of products as per the latest regulatory requirements
• Prepare and review SOPs, guidelines and checklists used by the R&D teams
• Ensure timely reporting of drug safety and quality complaints received from the PV team, to related authorities
• Coordinate with the Legal team to review agreements, CDAs, CTA to be compliant

5. Major Challenges
Keeping pace with the frequently changing compliance requirements, market dynamics/ therapy
treatment trends and medical information overload
• Managing multiple stakeholders and interdependencies on other cross functional teams
• Scientific communication being highly regulated for the pharmaceutical sector, poses a challenge in terms of off-label promotions and copyright limitation on images (graphs, tables, algorithms etc.) making it difficult to balance between ethics and marketing needs

6. Key Interactions
Internal External
• Marketing Team for promotional inputs (daily) • Conference Committees for publications,
• Sales Team (India & international) for field lectures, posters etc. for conferences (need
queries, CME meetings and refresher, based)
launches twice a month etc. (daily) • Chemists for competitor insights and patient
• Clinical Trials for discussions on trial feedbacks (bi-monthly)
protocols, status and other inputs (need based) • DCGI for product approval presentation
• Pharmacovigilance & CQA for product quality (occasional)
and SAE complaints (need based) • KOLs for knowledge sharing (need based)
• Compliance & Ethics to ensure promotional • Medical and nonmedical institutes/
activities in line with compliance guidelines associations/ Paramedics to partner in
(need based) research projects, educational activities, etc.
• Legal for reviewing contracts, copyrights and (need based) disclaimers (need based) • Marketing/ Medical agencies for promotional
• Corporate for press releases, Cipla Med, inputs (need based) counsel activities (need based)
• Finance for financial discrepancies (need based)
• Art department for review and suggestions on conference collaterals and product pack designs (need based)
• Learning and Development for Esproute related & training (need based)
• Medical QAG for SOP review (monthly)
• JP precision (Cipla Subsidiary. Division specific.)
• Cipla Health (Day to day working for some colleagues)
• R&D/ Portfolio for product development (need based)
• Packaging/ Art Team for new product package
design (need based)
• Library (daily for research articles)
• Corporate Communications & CiplaMed for
therapy related inputs (2-3 times a week)

7. Dimensions
Scope of work handled • Therapies: 1-2
• Brands: 5-15
• Team Size : 1-2 members
• Marketing team strength supported: 3-12
• Field force supported: 200-1000
• Scientific resource creation (medical abstracts, product guides, publications, CiplaMed inputs etc.):
~70-100 documents/ deliverables per year
• Deliverables for medico marketing initiatives (LBL, new product launch, campaigns, webcasts,
conferences, surveys etc.): ~80-100 documents/ deliverables per year
• Training material creation (Esproute, refreshers, Nalanda, product launch training, PMT, BM/SM etc.):
~50 documents/ deliverables per year • Conference participations: ~4 per year • Fieldwork: ~1-6 field visits per year
• KOL development: ~1-3 new KOLs per year
• Regulatory/ PV deliverables (SOP, package inserts, CDAs, PV queries etc.): ~20-25 per year
8. Key Decisions:
Decisions Recommendations
• CiplaMed content approval (created by outsourced team)
• Addressing field & doctor queries
• Approval of scientific communication for doctors/ field queries
• Training material for field
Comments:

Approval required from Group Lead on the following
• KOL engagement activities
• Topics for scientific meetings
• Organising online training module
• Portfolio suggestions
• Strategies for promotion of drugs
• Deciding field work agenda and territory
• HO initiated scientific events
• Approval of promotional inputs
• Scientific publishing/ clinical trial related
activities
• Attending conferences/ conducting field work
• Drafting patient education material
• New product activities
• Package insert content, promotional inputs

9. Skills & Knowledge
Educational qualifications:
Postgraduate in Pharmacology (MD) with a background in MBBS

Relevant experience:
• 1 - 2 years experience with MBBS/ MD

Skills required:
• Medical writing, Medical therapy experience, Medical scientific publications, Medical training
expertise, KOL development, knowledge of Compliance Regulatory Affairs & Clinical Trials