Medical Services Senior Specialist

Job Description

The Position:

The Medical Services Sr. Specialist will report to the Medical Services Manager for Mid Europe (i.e. France, Belgium, Luxembourg and Switzerland) and oversees the DPOC/Medical Information and Medical Review activities for Belgium/Luxembourg and to a minor extent for Switzerland.

The primary responsibility of the Sr. Specialist Medical Services is to have oversight and coordinate the DPOC/Medical Information requests managed by the vendor and to ensure the highest standards in medical review of promotional and non-promotional communications (materials).

Responsibilities:

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

• Ensure management and quality control of the DPOC (designated point of contact) 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 and ensure that vendor delivers the required work.
• Ensure that DPOC vendor researches, assesses, and compiles responses from published and unpublished literature to create responses that are medically and scientifically accurate, timely and fair balanced.
• Assure that the 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) and identify gaps within the medical information process and provide rapid resolution.
• Ensure the set-up of standardized answers for frequently asked questions or routine requests.
• Maintain ongoing communication with different internal stakeholders, such as PV and quality team, commercial team and operations.
• Support and train Medical Advisors/Medical Science Liaison and other staff in the management of DPOC/Medical Information Requests.
• Generate and report monthly key performance metrics.

Medical Review

• Manage the processes related to 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 country.
• Review and approve promotional materials to ensure content is relevant,
• scientifically accurate, and consistent with company values and standards.
• RIP (Responsible for Information & Publicity): Responsible for final approval of promotional and non-promotional materials in Belgium/Luxembourg.
• Ensure that medical review of materials is completed with accuracy and in a timely manner, meeting company policies and country regulations prior to public release.
• Provide compliance leadership and training to internal stakeholders.
• Oversight of vendor which performs deputy RIP activities during holidays and which performs medical and legal review on behalf of Organon.

General

• Lead and monitor local priority activities.
• Contribute when needed to the simplification of standard operations/processes related to medical operations in respect of local rules and regulations.
• Act as point of contact for DPOC/Med Info processes, as well as for Medical Review operations.
• Create, manage, and own local DPOC/Med Info Working Instructions (WI) and Promotional Material review checklist.
• Ensure and support audit & inspection readiness for Medical Information & publicity at all times

Required Education, Experience, & Skills:

• A Medical degree, PhD, or Pharm D
• Minimum 5 years of experience in the pharmaceutical industry
• Experience in project management and effective organizational skills.
• Experience in Medical Information & Medical Review
• You have excellent communication and interpersonal skills, a strong personal integrity and you are teamplayer
• You demonstrate effective organizational and project management skills, including the ability to set goals and align priorities, and work effectively
• You have experience interacting with cross-functional teams and ability to collaborate effectively in order to ensure the proper alignment and accelerate the approval process
• You have marketing affinity and business understanding
• You exhibit good knowledge of Medical information and publicity work and are able to understand and apply SOPs and regulations related to promotional review, DPOC and Medical Information
• You are able to work with internal and external partners to maintain high quality outcomes of DPOC/MI operational processes
• You are able to identify and escalate risks/issues that arise within ORD functional areas
• You can manage the different systems related to the position and will perform KPI analysis on regular basis
• You have a thorough understanding of ethical guidelines, laws and regulations relating to the biopharmaceutical industry
• Experience with vendor management is an asset
• Languages: Dutch and French (either both or one of these as native language) and excellent English (written and spoken)
• Be entitled to a RIP number from FAGG /AFMPS and if you already hold it, this is considered as a plus
• You can work autonomously and at a high standards

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 Women’s 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. 

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 Carefully 

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. 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. 

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R526909

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