Medical Information Director

Medical Information Director

Curium

France

OVERALL MISSION

The Medical Information responsible is in charge of medical information for CURIUM, and for the products distributed by CURIUM (belonging to other MAHs). This contains the following:

• Regulatory affairs: Supports regular updating of the clinical information on CURIUM radiopharmaceuticals with respect to collected peer-reviewed data). Delegate participation of the Medical Approver for the EU SPECT and EU PET LMR Committee;
• Medical affairs: medical information, follow-up of medical questions collected from subsidiaries, distributors or customers or can be delegated to MSLs. Management of cases with pharmacovigilance and materiovigilance departments. Regular training of Sales resources (place of the radiopharmaceutical in the strategy tree of treatments, right use of the drugs). Medical writing activities i.e. product related slide decks, corporate abstracts, posters, oral presentation and manuscripts when appropriate. Stays abreast of emerging scientific literature and clinical trial data, translates the data in applicable knowledge and develops scientific materials for key internal audience i.e. sales forces trainings. Medical support to Strategy business department. Medical support to Marketing Team and Real-World-Evidence Team. Runs and provides medical input into the selection of Investigator Initiated Studies (voting participant at Scientific Review Board, participant at Operational Review Board, responsible of contact with the Investigator Applicant). Compassionate Use and Named-Patient Programs.

Essential Functions

DESCRIPTION OF RESPONSIBILITIES

• Regulatory affairs: supports the job duties of the Assistant Director of EU Medical Regulatory Assistant Director;
• Responsible of Medical Information department:
  • The person must be fully familiar with nuclear medicine products and their indications and uses as well as current literature on them;
  • is responsible of medical information and standard response letters; answers to medical questions collected from subsidiaries, distributors or customers, in due time that can also be delegated to MSLs;
  • supervises the medical information department; defines yearly objectives and timelines, is in charge of yearly competence evaluation.
• Medical affairs: Supports the regular training of Sales resources (for certification purposes). Helps ensure responses to questions of Medical Affairs are correct, accurate, and standardized. Runs the Curium IIS Program.

ADDITIONAL RESPONSIBILITIES

Is responsible to support the training of the Medical Affairs team: training on radiopharmaceuticals, training on nuclear medicine procedures, introduction to national agencies representatives, introduction to key opinion leaders and nuclear medicine physicians.

Requirements

GENERAL KNOWLEDGE OR QUALIFICATION:

• Doctoral level candidate (MD, Pharm.D., Ph.D.) with confirmed experience in radiopharmaceutical industry (minimum of 10 years);
• Experience in providing Medical Information-level support of radiopharmaceuticals and good medical writing skills;
• Awareness of NA, European and ICH regulations and guidelines related to clinical development, medical affairs and pharmacovigilance;
• Excellent medical and English communication skills: fluent read, written and spoken English;
• Familiar with the medical, legal, and regulatory aspects of running IIS, CU, and NPPs.

SCIENTIFIC KNOWLEDGE:

• Medical knowledge, including knowledge in nuclear medicine and oncology;
• Knowledge of CURIUM Europe and NA radiopharmaceuticals.

TECHNICAL SKILLS:

• Excel, Word, Power Point, MSTeams, Sharepoint, Veeva;
• Global procedures.

PRACTICAL KNOWLEDGE OF COMPANY OPERATION:

• Knowledge of CURIUM organization and distribution network organization.

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