Medical Advisor

Summary / purpose of the position

• As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information exchange, supporting data and insight generation to provide patient-centric solutions in assigned area.
• The MA/MSL is a scientific point of contact for the assigned therapeutic area internally in Ipsen, with focus on review of promotional and nonpromotional materials, medical training of internal stakeholders and other activities related to medical advisory role. The MA/MSL must maintain up-to-date knowledge of relevant scientific information.
• The MA/MSL works in coordination with the rest of the Medical Department to meet the Medical Department objectives.
• Directs all aspects of organization´s medical policies, standards and programs and ensures all medical activities are compliant with all applicable local regulations.

Main responsibilities / job expectations

• Support to clinical development & ISS (data generation)

• Coordinate and facilitate unsolicited Investigator‐Sponsored Study (ISS) requests from submission until completion, presentation, and publication, in alignment with Medical Affairs' objectives

• Support the R&D projects and Company Sponsored Studies (CSS) operations (investigators site identification and evaluation, feasibility studies, recruitment, investigator meetings, external expert identification, study management, investigators query) when appropriate
• Support the implementation and follow‐up of post-marketing clinical activities such as registry/database projects, epidemiological surveys, post‐authorization studies (phase IV) at the site level

• Identify opportunities to generate real‐world‐evidence data

• Ensure internal cross‐functional collaborations as a scientific partner

• Ensure development and maintenance of a medical and scientific information service in the key areas to provide support to Health Care Professionals
• Participate at brand teams´ work and campaigns preparation
• Provide inputs to the Medical Budget and Local Annual Medical plans, to participate on preparation of brand strategic plans with focus on their medical parts

• Keep high scientific profile and medical knowledge within assigned therapeutic area

• With the commercial staff (Marketing or Sales) to:

• Provide scientific expertise and training to commercial staff as required
• Review promotional materials in accordance with the local SOP.
• Contribute to the review and approval of non‐promotional materials in accordance with the local SOP
• Attend the local brand teams to bring additional scientific perspective
• Attend and contribute to regional account planning/training sessions
• Ensure speakers briefing for promotional meetings

With Market Access department to:

• Respond to requests to support hospital formulary submissions and upon request to present the data on Ipsen products

• Respond to scientific inquiries to deliver scientific presentations on the disease area and on the product

• Regulatory, Pharmacovigilance, Medical information

• In RA, cooperate with local service providers on revisions of prepared RA texts, local submissions. To provide Local Quality with consultancy support whenever requested.

• In PV, cooperate with PV, RA and marketing on implementation of RMPs and aRMMs. To provide Local Quality with consultancy support whenever requested.
• Complete all pharmacovigilance trainings, ensure the accurate, timely reporting and follow-up activities of all adverse events and special situations reports.

• To provide medical information support according to relevant IPSEN requirements, to use the MI system properly. To ensure high quality in providing MI services across therapeutic areas within the affiliate.

• Establish and foster professional collaborations with the Healthcare community

• Map the scientific expertise: identify, complete and update Thought Leaders (TL) database in assigned therapy area in accordance with the Global MSL Directive and the TL Tiering Process

• Conduct fair and balanced scientific exchanges with TL to explore mutual clinical and scientific interests, insights generation, scientific/educational meetings (congresses, symposia, etc.), potential research collaborations
• Identify opportunities for collaboration with TL when aligned with Ipsen strategy
• Develop and enhance scientific and educational collaborations with Healthcare Professionals (HCP) within the Healthcare community and act as a medical contact for TL and external medical experts
• Reactively respond to unsolicited and documented queries from HCP. Record the medical inquiries in Medical Information System (MISTRAL) according to relevant SOP.

• Report accordingly to Veeva CRM system, based on MSL Directive, MSL metrics SOP and other relevant requirements

• Develop and/or implement unbiased and non‐promotional scientific exchange meetings and educational activities

• Provide scientific/educational presentations to HCP:

• Reactively: on Ipsen products (on‐label and off‐label indications), on compounds in development
• Proactively: on disease area management (excluding single‐product presentation)
• Organize or support legitimate scientific exchange meetings
• Contribute to/implement medical education programs in the field
• Contribute to the scientific publication program, if required

• Organize satellite symposia in Regional (in‐country) congresses

• Generate and share insight from HCP to nurture Ipsen's strategy

• Collect, analyze, and report actionable insights from HCP related to disease state, unmet medical needs, local guidelines, therapeutic trends, competitive activities, compounds in development and the broader healthcare environment
• If appropriate, organize or support Advisory Boards at Regional level (in‐country), based on actual need
• Attend and report insights from major National and Regional medical congresses
• Engage and collaborate on specific initiatives with Patient Organizations in accordance with the Global Guidance on Interactions with Patient Organizations and individual patients
• Contribute to the dissemination of the information within the Company where appropriate

Knowledge, abilities & experience

Education / Certifications:

• Ideally Medical doctor / Master's degree in pharmacy (PharmDr., Mgr.); university degree in biological studies required

Experience:

• Minimum 5 years of experience in Medical department of multinational company
• Ideally proven experience and successful track record similar role
• Experience in delivery of scientific presentations and development of relationships with Thought Leaders is strongly preferred
• Knowledge in data analysis and statistics for purpose of understanding clinical study results
• Ideally, experience in assigned therapeutic area
• Experience in creation and implementation of local medical plans and expenses budget management
• Experience with management of clinical studies, regulatory and pharmacovigilance (advantage).
• Medical/paramedical Practice or Research career (hospital and/or hospital related, university research, pharmaceutical industry research or medical affairs – advantage)
• Ideally, current working knowledge of legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals

Languages:

• Fluent in English, excellent verbal and communication skills

Other abilities:

• Driving license
• Computer literacy
• Project management