Medical Services Manager
Il y a 4 mois
Job Description
The Position
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. Â
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 Â
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
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Womenâs Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.Â
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.
Search Firm Representatives Please Read CarefullyÂ
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. Â No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Â
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
No Travel RequiredFlexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R526265
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