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    Medical Affairs Manager, UK - Brussels, België - Guerbet

    Guerbet
    Guerbet Brussels, België

    1 dag geleden

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    Long-term/regular
    Beschrijving

    OUR OFFER

    You will be the signatory medical doctor or pharmacist qualified person for the cluster. A registration as local Qualified Person in Pharmacovigilance (QPPV) for Benelux is desirable.

    The Medical Affairs Manager Cluster lead will bring strong leadership qualities, high level of cross-functional collaboration and the ability to influence across all levels of the organisation. Passion for the patient community and commitment to patient advocacy are paramount for this position:

    I- Common missions for this position

    Pharmacovigilance (PV)

  • Implements locally the PV policy according to the Group PV policy, strategy and objectives as defined by the Head of the Corporate PV department.
  • Is in charge of the local scientific and regulatory intelligence in PV. Provides his/her expertise and support to analyze the impact of new regulations and to apply them. Is responsible for the local compliance with the applicable quality referential and their evolution in his country.
  • Evaluates and follows the risks associated with the clinical use of pre- and post-marketing pharmaceutical products of the Group in his/her country.
  • Proposes measures intended to minimize these risks, to promote the best usage of the products and to guarantee the patients' safety in his/her country.
  • Identifies the critical information on his/her perimeter and is involved in its collection, analysis, utilization, circulation, protection, and archiving.
  • Is responsible for the update of the quality documentation related to PV. Provides his/her colleagues with these documents and explains them.
  • Develops the competencies, the performances, and the implication of the local team in PV.
  • Defines and coordinates the needs for training and the resources involved in PV in his subsidiary.
  • Is the reference person in PV working at the interface with the authorities, as well as customers and suppliers.
  • Is the contact person dealing with the authorities and healthcare professionals on his perimeter.
  • Prepares and follows the course of the inspections and audits. Is involved in the local implementation of the preventive and corrective actions.
  • Follows the recommendations and guidelines about health, safety, and environment.

    • Regulatory affairs (RA) subcontracted.

  • Is the contact person dealing with the authorities for RA
  • Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by Corporate RA department. Submits variations, renewals, or new marketing authorization applications to his competent authority. Attaches any relevant documentation according to the local requirements.
  • Is in charge of the follow-up of the pending approvals. Answers some questions and provides additional documentation when requested by the agency. Informs the pharmacists from the Corporate RA department about the approval status of the dossiers.
  • Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulation.
  • Proposes some regulatory strategies based on his/her experience and knowledge of the local regulatory and quality laws.
  • Revises and validate the texts of the packaging materials of the products.

    • Pharmaceutical affairs

  • Manages product quality complaints.

    • Quality assurance

  • Checks the compliance with the good practices (GMP, GDP, GCP).
  • Implements locally and communicates about the quality assurance system and its evolution.
  • Writes, revises, gives out and maintains the locally applicable quality assurance documentation.
  • Organizes audits and implements the corrective actions in the subsidiary.

    • Scientific information

  • Revises and approves promotional materials according to the law in force.
  • Revises and validates the scientific documentation used for the education of the sales force (e-learning...).
  • Performs the scientific training of the sales representatives about products and imaging techniques. Performs some trainings about new regulations in PV or RA applicable to the products.
  • Provides a scientific support to the local Sales and Marketing people.

    • Medical advisoring

  • Is responsible for providing medical information whenever a customer is asking a scientific, medical or radiological question related to the products.
  • Participates to the Medical Information Network dealing with such questions at the Group level.
  • Gives lectures in hospitals when requested by a customer or a sales representative about scientific topics related to the Group products or to techniques in medical imaging.
  • Communicates with experts and key opinion leaders.

    • Clinical studies

  • Is the contact person dealing with the authorities and ethical committees
  • Identifies clinical sites with potential investigators for future clinical studies. Proposes them to the Corporate Clinical Development department.
  • Checks the compliance of the documentation sent by the Clinical Project Manager with the nationally approved texts of the product characteristics. Submits it to the competent authority and the ethical committees. Attaches any relevant documentation according to the local requirements.
  • Follows the progress of the clinical study authorization application. Answers some questions from the authorities or ethical committees after discussion with the Clinical Project Manager. Informs him/her when the study can start.
  • Manages the contract signatures with the principal investigators and the heads of the hospitals involved in the study.
  • Manages the queries from the case report forms of patients participating to post-marketing observational studies.
  • Oversees the local regulatory intelligence. Informs the Corporate Clinical Development department about new regulations applicable to clinical studies.
  • Manages the proposals of investigator-initiated studies: collects the study protocol, performs a literature search, makes a recommendation to the Corporate Medical Affairs Manager, manages the contract signature after approval and is in charge of the study follow-up.

    • II- Specific missions for this position

    (Geographical perimeter = Benelux)

  • Registered as local Qualified Person in Pharmacovigilance (QPPV)
  • Registered as Responsible for Information and Publicity (RIP) in Belgium

    • YOUR PROFILE

  • Pharmacist or medical doctor with sufficient experience and qualifications to locally mange PV and RA activities, and with good knowledge about the administrative tasks related to clinical studies.
  • Good competencies in contrast media and medical devices are an asset
  • Relevant scientific degree essential (MD, PhD or PharmaD).
  • Minimum 5 years Biotechnology/Pharmaceutical field experience.
  • Fluent in English, Dutch & French both spoken and written.
  • Prior experience as a medical affairs manager is a must.
  • Proven track record of relationship development in the industry.
  • Proven ability and experience to present complex scientific data.
  • Prior exposure to complex matrix organizations or experience working as part of a virtual team is a plus.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

    • Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. or you can also call this number

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