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Medical Services Director
il y a 1 mois
Job Opportunity
Organon is seeking a highly skilled Medical Services Manager to oversee all local Medical Services activities for the Mid-Europe Cluster. This role will report to the Medical Affairs Director and be responsible for the strategies and execution of activities related to Medical Review of (non-)promotional materials and medical information for the cluster.
Key Responsibilities
- Manage and quality control of the vendor that performs the DPOC service, ensuring the receipt of cases, 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, including 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, including review flows, priorities, outsourcing, metrics, SOP, and 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 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.
Requirements
- 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.
