The Medical Manager is responsible for the implementation of the medical strategy (Core Medical Plan, “CMP”) with a focus in Women’s Health at the affiliate level by coordinating and executing medical / scientific activities to (i) understand the local external environment and data gaps; (ii) translate insights into strategies and activities and (iii) ensure the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use of products.Specifically, this individual will: Provide strategic medical and scientific expertise in support of all affiliate Medical Affairs deliverables and cross-functional activities Demonstrate matrix leadership by developing and maintaining integrated partnerships with key internal and external stakeholders to ensure all MA affiliate activities address local needs and advance the medical/scientific understanding of products across their lifecycle Responsible for understanding and engaging external stakeholders to advance the understanding of and science behind compounds in development, the safe and effective use of products and disease states that they treat. Responsible for engaging and working closely with key internal stakeholders, including the brand teams across the affiliate to achieve business objectives for the affiliate. Ensures all affiliate MA activities deliver value and are based on scientific validity, clinical importance and on time and budget.Essential Job DutiesUnderstand External Environment and Data GapsScientific Intelligence
Demonstrate thorough understanding of the therapeutic area, it’s current status,
unmet needs and future developments
Engage external stakeholders (such as health care providers, payers and decision
makers) and gather as well as share competitive scientific intelligence
Develop and maintain in depth scientific and medical expertise of assigned
therapeutic area through self-study, company-provided training and scientificmeeting attendance in order to enhance the contribution to the companyAdvisory Boards
Conduct advisory boards as needed per the life cycle of the product to seek expert
advice, opinions and feedback from advisors and other stakeholders on medical,humanistic, health economic or clinical topics related to marketed products ordevelopment-stage compounds to inform medical affairs and commercial strategies,plansMedical Insights
Collaborates cross functionally with internal stakeholders to support communication
of relevant scientific and medical insights to internal stakeholders
Oversee medical insights generation activities and ensure actionable insights are
incorporated in strategic planning processes in collaboration with operationalexcellence and regional TA leadsTranslate Insights into Strategies and ActivitiesCore Medical Plans
Identify the unmet needs and develop suitable medical strategy to incorporate in the
CMP as well ensure a compliant execution of all Affiliate Medical/Scientific activities(including vendor oversight) i.e. launch activities, educational programs, advisory /expert meetings, symposia in congresses
Ensure the affiliate CMP is aligned with Global CMP, Integrated global brand plan, as
well as local brand strategies
Strategically leverage regional and/or global medical initiatives to meet local business
needs, while maintaining an enterprise view
Implement the affiliate CMP tactics for the TA, on time and on budget as well as
update CMP trackers on timeCollaboration Within M&D
Provide reactive support to development team to identify potential study investigators
/ sites and assist with feasibility study execution for registration studies.
Provide scientific/medical support to regulatory affairs on submission of dossiers and
presentations upon request
Provide scientific/medical support to regional clinical operations and/or
pharmacovigilance teams in execution of mandatory post-approval studies asneeded.
Partner with Regional Operational Excellence team to provide regular input to monthly
reports for the General Manager/Regional President/Chief Medical OfficerCollaboration with Commercial
Provide strategic scientific/medical expertise in support of all cross-functional
activities (Marketing, Market Access, Business Intelligence, Sales)
Champion a collaborative mindset to ensure full alignment with key stakeholders’
cross-functionally
Review and approve promotional materials complying with local and applicable
internal/external regulations and/or policies.
Provide scientific /medical support to Marketing, Market Access, Business Intelligence
(advice, reports, recommendations, etc.).
Coordinate in executing medical-scientific activities in product launches: disease area
presentations, expert meetings.
Participating as a therapeutic area/product expert in internal meetings of the company
and provide medical-scientific support for external meetings in a fair and balancedmanner (post-approval symposia)
Provide consistent training on therapeutic area and products to the colleagues
(including commercial) in the affiliateFulfill Information Needs of External StakeholdersData Generation for HCPs and Payers
Partner closely with the Health Economics and Outcomes Research (HEOR) and
Market Access to provide insight on local access strategies and challenges and closedata gaps
Plan and develop HEOR data generation projects, not limited to Budget Impact Model/
Cost-effectiveness analysis
Partner with market access in reimbursement or listing discussions with
payers/hospitals as neededData Communication and Medical Education
Provide medical / scientific education and training to internal stakeholders on
marketed products and compounds in development
Acts as local scientific/medical expert to regional Medical Information group (i.e.
escalated inquiries), ensuring all local regulatory requirements are met and incompliance with Astellas procedures and ethical standards.
Strategically manage the development of local Non-Promotional Medical Materials in
alignment with TA/ affiliate objectives, including, but not limited to slide presentationsand posters / manuscripts
Identify and engage key external customers (KEEs) in in-depth medical and scientific
product or disease area discussions / scientific exchange, and presentations tocommunicate the value of Astellas products in a fair and balanced way in accordancewith Astellas values/code of conduct as well as applicable local regulations
Develop, maintain, engage with key external experts (KEEs), healthcare
professionals, healthcare organizations funding bodies and other entities to engageand communicate the value of Astellas products in a fair and balanced wayaccordance with Astellas values/code of conduct as well as applicable localregulationsExternal Program Funding for Research and Education
Support the affiliate head and regional reviewers in reviewing as well as appropriate
documentation of Investigator Sponsored Research/ Grants for general research/Grants for Medical Education/ Sponsorship for Research & Education
Obtain post-activity evidence, including financial reconciliation documents to confirm
that the provided grant support was utilized according to the executed legalagreement and this is documented in the applicable systemCompliance & Governance
Ensures all affiliate medical affairs activities are in compliance with all applicable
Astellas policies, external regulations and ethical standards
Partners with Ethics & Compliance to review commercial led promotional tactics and
inputs to ensure adherence to compliance in all areas of operations.Field Medical Activities· An office-based hybrid professional Medical Affairs leader responsible foridentifying, accessing and effectively engaging with key external experts to fosterscientific exchange and mutually beneficial collaboration.Required Qualifications· Doctoral degree (MD, PhD in health-related science or PharmD)· Minimum 4 years’ experience in Pharma.· 3-5 years’ experience in Medical Affairs· Suitable candidates from academia with strong expertise in the therapeutic areaincluding clinical/ hospital practice, clinical development, experience in designing,executing and reporting of clinical trials can be considered.· Strong understanding and knowledge of industry laws and regulations.· Experienced in managing complex projects and effectively act independently(ex. Ad Boards, Publications, Preceptorship).· Demonstration of ability to effectively interact in a matrix organization with matrixreporting lines.· Proactive strategic partnering with different internal functions(ex. Commercial, Market Access, HEOR.)· Excellent presentation skills and advanced written and verbal business English.· Foundational understanding of the drug development process as well ascommercialization.· Ability to travel 20-30% of the time including overnight travelPreferred Qualifications· Demonstration of delegated responsibilities successfully completed e.g., acting as aback up for a Therapy Area Lead at key internal or external meetings.
