Présentation de la société : IPSEN PHARMA
Ipsen est un groupe biopharmaceutique mondial spécialisé dans le développement de médicaments innovants en oncologie, en neurosciences et dans les maladies rares.Notre objectif est d’améliorer la qualité de vie des patients. Ipsen bénéficie également d’une présence significative en Santé Familiale.
Nous sommes engagés dans la recherche de solutions nouvelles à des maladies invalidantes ciblées et pour l’amélioration de la qualité de vie du patient.
Chez Ipsen, nous avons une mission claire: améliorer la vie des patients. Travailler avec les patients, pour les patients est plus qu'une aspiration. C'est l'unique moyen de garantir la création d’une valeur partagée, tant pour les patients que pour nos collaborateurs
Missions
Reporting to the Senior Director, Medical Affairs, the Senior Manager, Medical Affairs Reviewer, 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 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.
WHAT - 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.
- Identify, recommend, and support continuous improvement of the MRC/PRC (i.e. Strength of evidence in references, appropriate requests to amend materials) .
- Ensure timely completion of all assigned reviews and follow-up actions in accordance with established timelines.
- Participate in scheduled MRC and PRC meetings and contribute to discussions as needed.
- Collaborate with project owners to ensure all requests for additional information/annotations get completed.
- 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.
- May attend 1-2 congresses to support scientific exchange and congress coverage activities.
- 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
Profil recherché
Knowledge & Experience (essential) :- 3-5 years’ relevant experience with at least 1-2 years in Medical Affairs with a strategic focus, including at least 2 years in the biotech/pharmaceutical industry.
- Medical Reviewer or Regulatory Affairs Experience.
- 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%)
- Experience in presenting and publishing scientific information a plus.
- MD, PhD or PharmD required.
- Fluent in English