Independent Medical Reviewer (m/f)
That's XPE. For one of our clients we are looking for: Independent Medical Reviewer (m/f) Organisation description:
For one of our partners, a pharmaceutical company, XPE is looking for an INDEPENDENT MEDICAL REVIEWER (IMR) to join their current team, in Wavre.Job description:
Purpose of the mission: As IMR, you'll:
- Be involved in multiple cross functional areas such as medical, commercial, regulatory, legal, etc. during the process of Development, Review of Materials/activities covered by the company code of Practice. He/she will ensure partnership with teams at LOCs level in order to better understand their needs and timelines.
- Ensure the balance, accuracy and appropriateness of the content of the materials/activities and that they comply with all applicable codes and relevant POLs and SOPs, will prevent potential risk for the company (internally and externally).
- Interact with and inspire key stakeholders to contribute to the accuracy and compliance of materials/activities governed by the Code of Practice.
You primary Tasks & your responsibilities:
- Participate and provide medical & compliance input in the mandatory meetings previous to the development of the materials/activities covered by the company Code of Practice and Customers Interactions (e.g. Kick-Off meetings).
- Critically appraise and recommend changes to materials/activities to ensure balance of the messages, medical accuracy and appropriateness of the content of the materials/activities in alignment with codes and other relevant POLs and SOPs.
- Accountable for Review and Certificate the materials through the electronic tool ZINC (Since the candidate will be in charge of the review of 2 or more vaccines, the respective GMAL of the disease/product area will certificate the suitability of the Medical Reviewer in terms of content).
- Participate in the Project Closure, providing the appropriate feedback.
- Work across boundaries, building a strong network with other stakeholders involved in the process.
- This role will provide coaching and support to other medical junior reviewers and to other stakeholders involved in the process of the Development, Review and Certification of the materials covered by the company's Code of Practice (you will be a Champion in the new process).
- Participate in different internal and external meetings (training, educational and others, including medical congresses) to guarantee that you will be periodically updated on the relevant therapy areas about the medical/scientific new information and the commercial strategy.
- Ensure partnership with teams at LOCs level in order to better understand their needs and timelines.
You're our candidate if you recognize yourself in the following aspects: Hard Skills:
- Knowledge/Expertise in infectious diseases and vaccines in general would be a strong asset
- Knowledge/Expertise in the designated diseases/products area acquired through education, readings, daily work, attendance to meetings and congresses.
- Experience within the pharmaceutical industry;
- Understanding of the ethical, regulatory, compliance & medical governance framework related with materials/activities covered by the company's Code of Practice
- Fully knowledgeable regarding Industry and codes, POLs and SOPs related
- Local /Regional experience is an asset
- Familiar with the company's portfolio and competitors' vaccines
- Collaborative approach, trying to find solutions and consensus, sticking to the rules is crucial.
- Teaching/coaching skills preferred.
- Must be capable of interacting with and inspiring key stakeholders to contribute to the accuracy and compliance of materials/activities governed by the Code of Practice.
- Managing the interfaces in a multidisciplinary/multicultural matrix structure and in a fast-moving and changing environment.
Education, Methodology & Certification Requirements: University Level ( Medical Doctor or scientific PhD could be considered). Area of specialisation: Vaccinology, Immunology, Paediatrics, Infectious Diseases. Certification as a Reviewer/Certifier according to the appropriate process would be a plus! ICT Skills (software, operating systems, hardware, etc.) MS office Suite Language Proficiency Requirements: English: fluent French: beneficial Other international languages are considered as an assetOffer:
XPE offers you a permanent contract to work in an international environment and a Great place to work
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713