Medical Manager

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 Duties

Understand External Environment and Data Gaps

Scientific 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 scientific

meeting attendance in order to enhance the contribution to the company

Advisory 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 or

development-stage compounds to inform medical affairs and commercial strategies,

plans

Medical 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 operational

excellence and regional TA leads

Translate Insights into Strategies and Activities

Core 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 time

Collaboration 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 as

needed.

• Partner with Regional Operational Excellence team to provide regular input to monthly

reports for the General Manager/Regional President/Chief Medical Officer

Collaboration 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 balanced

manner (post-approval symposia)

• Provide consistent training on therapeutic area and products to the colleagues

(including commercial) in the affiliate

Fulfill Information Needs of External Stakeholders

Data 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 close

data 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 needed

Data 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 in

compliance 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 presentations

and posters / manuscripts

• Identify and engage key external customers (KEEs) in in-depth medical and scientific

product or disease area discussions / scientific exchange, and presentations to

communicate the value of Astellas products in a fair and balanced way in accordance

with 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 engage

and communicate the value of Astellas products in a fair and balanced way

accordance with Astellas values/code of conduct as well as applicable local

regulations

External 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 legal

agreement and this is documented in the applicable system

Compliance & 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 for

identifying, accessing and effectively engaging with key external experts to foster

scientific 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 area

including 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 matrix

reporting 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 as

commercialization.

· Ability to travel 20-30% of the time including overnight travel

Preferred Qualifications

· Demonstration of delegated responsibilities successfully completed e.g., acting as a

back up for a Therapy Area Lead at key internal or external meetings.