Medical Services Manager

Organon; Paris; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un Manager des Services Médicaux pour superviser les activités médicales dans la région Mid-Europe. Ce rôle clé implique la gestion d'une équipe dédiée à la révision médicale et à l'information médicale, en veillant à la conformité avec les réglementations locales. Vous serez responsable de la gestion des processus de révision des matériaux promotionnels et non promotionnels, tout en assurant la qualité des communications médicales. Si vous avez une solide expérience dans l'industrie pharmaceutique et un excellent sens de la communication, cette opportunité pourrait être votre prochain grand défi.

Qualifications

• Minimum de 5 ans d'expérience dans l'industrie pharmaceutique.
• Expérience en gestion d'équipe et en gestion de projet.

Responsabilités

• Superviser les activités de révision médicale et d'information médicale.
• Gérer les processus de gestion des informations médicales et des matériaux promotionnels.

Connaissances

Gestion d'équipe

Compétences en communication

Compétences organisationnelles

Gestion des fournisseurs

Compréhension des réglementations

Collaboration interfonctionnelle

Formation

Diplôme médical, PhD, Pharm D ou autre diplôme en sciences de la vie

Description du poste

The Medical Services Manager reports to the Medical Affairs Director and oversees all local Medical Services activities for the Mid-Europe Cluster (France, Belgium, Luxembourg, and Switzerland).

In this role, he / she oversees the strategies and execution of activities related to Medical Review of (non-)promotional materials and medical information for the cluster. He / she supervises and leads a team with people dedicated to medical review and / or medical information, in compliance with the applicable rules and procedures, and ensures the development of their skills and knowledge.

Responsibilities

DPOC (Designated Point of Contact) & Medical Information Process Management

Ensure management and quality control of the vendor that performs the DPOC service; this includes the receipt of cases (i.e. medical information requests, adverse events, product quality complaints), the classification, and appropriate routing of cases for further processing to meet regulatory and business requirements.

Assure the DPOC database is accurately maintained.

Manage the processes related to medical information (i.e. response to or triage of unsolicited on-label and off-label inquiries received from healthcare providers and other external and internal stakeholders).

Ensure the set-up of standardized answers for frequently asked questions or routine requests by the Medical Information Specialists.

Ensure that responses to medical inquiries by the Medical Information Specialists are high-quality professional communications.

Identify gaps within the medical information process and provide rapid resolution.

Maintain ongoing communication with different internal stakeholders, such as PV and quality teams, commercial teams, and operations.

Generate and report monthly key performance metrics.

Medical Review

Manage all the processes related to (non-)promotional material review and approval (i.e. review flows, priorities, outsourcing, metrics, SOP, implementation of regional initiatives).

Be knowledgeable of the different regulations and laws governing promotional materials in the defined countries (France, Belgium, Luxembourg, Switzerland).

Ensure that the medical review of materials by the medical reviewers is completed with accuracy and promptly, meeting company policies and country regulations before public release.

Ensure final approval of promotional and non-promotional materials in the defined countries (France, Belgium, Luxembourg, Switzerland).

Provide compliance leadership and training to country staff.

Team Management

Manage and lead the team daily and take responsibility for the recruitment and successful integration of new employees.

Develop employees (individual priorities / development actions / training) around key skills and ensure follow-up through local coaching.

Foster and maintain a climate within the team that motivates and engages employees.

Promote and implement working methods that encourage collaboration, autonomy, and innovation within teams.

General

Lead and monitor local priority activities, applying project management skills.

Represent the cluster in regional and global teams, meetings, and projects.

Contribute when needed to the simplification of standard operations / processes related to medical operations concerning local rules and regulations.

Required Education, Experience, and Skills

People & team management skills

Excellent communication and interpersonal skills, strong personal integrity, team player.

Demonstrated effective organizational skills, including the ability to set goals align priorities, and work effectively in a constantly changing environment.

Experience interacting with cross-functional teams and ability to collaborate effectively to ensure the proper alignment and accelerate the approval process.

Ability to manage the different systems related to the position.

Vendor management is a strong asset.

Thorough understanding of ethical guidelines, laws, and regulations relating to the biopharmaceutical industry.

Languages: French, English. Dutch and / or German are an asset.

Minimum of 5 years of experience in the pharmaceutical industry.

Experience in managing, leading, and developing a team (1-5 direct reports).

Experience in project management and effective organizational skills.

Experience in Medical Information & Medical Review.

Medical degree, PhD, Pharm D, or other relevant life sciences degree.