VIE Senior Manager, Medical Affairs, Rare Disease

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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V.I.E (Volontariat International en Entreprise) is a program run by Business France the French government agency. It allows young professionals from the European Economic Area to work for a French company outside of France for a limited period. Participants are not Ipsen employees but have a special V.I.E status.

To take part in the program there are specific eligibility criteria that must be met and will be verified by Business France. Those who do not meet the eligibility criteria cannot be part of this program but can apply to other opportunities within Ipsen.

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Reporting to the Senior Director Medical Affairs the Senior Manager Medical Affairs Rare Disease will support the execution of medical affairs activities within the Rare Disease Liver therapeutic area.

The Senior Manager will contribute to the review of promotional and medical content assist in the implementation of medical strategies and help drive the overall execution of the U.S. Medical Affairs Rare Disease plans. Key internal partners include the U.S. Rare Medical Affairs team U.S. Rare Commercial team U.S. Regulatory U.S. Legal and Global Rare Disease franchise medical colleagues.

Main Responsibilities & Technical Competencies

• Conduct medical review of promotional and non-promotional materials as a member of the Medical Review Committee (MRC) and Promotional Review Committee (PRC) ensuring medical & scientific accuracy and compliance with applicable U.S. laws regulations and company policies as needed

• Participate in scheduled MRC and PRC meetings and contribute to discussions as needed

• Assist the Medical Communications Lead in the development of proactive and reactive field-facing materials (e.g. FAQs objection handlers advisory board content) incorporating input from field medical teams.

• Support the planning and execution of Medical congress activities (including but not limited to symposia booth materials meet-the-experts sessions cross-functional alignment and support)

• Contribute to develop and implement medical strategies that align with organizational goals and objectives.

• Serve as subject matter expert (SME) SME on medical and/or disease area and asset cross-functional committees as appropriate

• Contribute to and lead advisory board planning and execution activities as assigned

• As a SME the candidate will be responsible to train internal Medical and cross-functional partners on disease area and Ipsen product content

• Contribute to the U.S. scientific publication plan

• Attend relevant congresses to engage in scientific exchange and provide congress coverage

• Support the planning execution and budget oversight of medical activities relate to elafibranor

• Manage Personal Travel and Expense budget in keeping with Ipsen guidelines

• Complies with all laws regulations and policies that govern the conduct of Ipsen U.S. staff

Qualifications

Knowledge & Experience (essential):

• Minimum of 5 years relevant experience with at least 1-2 years in Medical Affairs with a strategic focus including at least 23 years in the biotech/pharmaceutical industry.

• Knowledge of clinical trial design biostatistics.

• Experience in Rare Diseases Hepatology or Gastroenterology.

• Able to evaluate interpret and present highly complex data for a series of studies.

• Demonstrated ability to collaborate effectively across cross-functional teams and diverse cultural environments fostering inclusive teamwork.

• Strong enterprise mindset with a focus on aligning individual contributions to broader organizational goals.

• Excellent written and verbal communication skills with the ability to convey complex scientific and medical concepts clearly and concisely.

• Analytical and strategic thinking skills with the ability to assess various scenarios and propose practical compliant solutions.

• Proven experience in project management including planning execution tracking and reporting of outcomes.

• Working knowledge of U.S. compliance standards including PhRMA Code OIG guidance and FDA regulations with the ability to apply these principles under guidance in medical affairs activities.

• Demonstrated ability to thrive in a fast-paced evolving environment with a high degree of autonomy and accountability.

• Strong interpersonal and problem-solving skills with a collaborative and solutions-oriented approach.

• Highly organized with the ability to manage multiple priorities and deadlines in a dynamic environment.

• Strong critical thinking and creative problem-solving capabilities.

• Ability to travel (up to 15%)

Knowledge & Experience (preferred): Experience in presenting and publishing scientific information a plus.

Education / Certifications (essential): MD PhD or PharmD required.

Language(s) (preferred): Fluent in English.