Modis is looking for a trilingual (FR, NL, EN) Responsible for Information and Publicity (RIP) for a pharmaceutical company, to sign a full time, permanent contract in direct with our client.
Main duty: ensuring the compliance to national regulations and global procedures related to information, advertising and medical samples management.
Department: Regulatory affairs
- Verification, when Regulatory Affairs Manager is missing, of the conformity of the SPC and patient information leaflets with their translations (FR,NL,DE) according to the approved EN reference texts.
- Providing the annual registry of medical samples.
- Redaction of the abridged SPC and safety pages and control of translations.
- Create/update all the relevant local standard operating procedures (SOP) and training all collaborators about it.
- Evaluate all promotional and informative materials and give approval (or refusal) before use.
- Take part of the management of any complaint and their follow-up related to promotional activities (IN & OUT).
- Validate all scientific events/meetings/sponsoring not subject to MDeon Visa
- Maintain registers of all promotional and informative materials and scientific events
- Perform training for Marketing/Promotion (including medical reps) staff.
- Perform regular spot checks in the following matters :
- Scientific events/congresses/sponsoring subject to MDeon Visa
- Premiums or benefits offered to health care professionals
- Medical sample and management tool
- Annual spot check of training department
- Annual spot check of the medical or scientific information request given by SIM
- Ensure to fulfill all the transparency‘s obligations defined by the Royal Decree of 14 June 2017 related to the Sunshine Act.
- Monitoring the medical environment and reporting emerging trends in the areas of the assigned products + their competitors.
- Maintaining a strong working relationship with sales and marketing teams.
- Act as Compliance relay for the HQ.
- Manage Jr. legal and compliance officer.
- Ensure all the implementations from HQ’s policies, directives and guidelines into local procedures.
- Act as Data Protection Officer (as defined by the GDPR entered into force from May 25th 2018).
- Provide support to business operations concerning compliance issues.
- Pharmacist or Medical Doctor
- RIP agreement number
- Excellent communication skills in French, Dutch and English
- Analytical, well-organized, rigorous, autonomous
Open-end contract with interesting advantages