Medical Information Officer

Summary Client is looking for a Germany -based Consultant with Regulatory or Compliance or Nominated Signatory Review experience as an Medical Information Officer for promotional and scientific communication materials (Pharmaceuticals). The regulatory consultant will work with Client’s material review team to support its engagement with the medical Pharmaceutical client partner and serve as a consultant to assist as an MLR SME (especially on Pharmaceutical advertising and promotion regulations) on Pharmaceutical project. Responsibilities Serve as an Information Officer for review of promotional and medical materials containing information on pharmaceutical company’s marketed products and compounds in development, as well as the corresponding disease states for Germany market Medical Information Officer will perform the Code Compliance Check and Final approval/Sign Off before approving asset, which is then released to Production. Ensure that medical and scientific information provided to patients and health care professionals is accurate and in compliance with the product’s marketing authorization and ensure the advertisements are in line with the German SPC and PIL including the approved indications. Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically balanced manner. Verify substantiation of all claims and comparisons. Determine acceptability of references, advise on whether claims are consistent with appropriate approved label, and ensure that the piece is relevant and of utility for the target audience. Check information and advertising materials and decide on the release, ensuring documentation, archiving and traceability of the disseminated advertising material and, if necessary, be the contact person for the authorities or bodies responsible for monitoring drug advertising. Advise on materials and events designed and produced by German marketing and medical teams to ensure compliance with company policies and German standards for ethical promotion and scientific interactions. Ensure the scientific information provided for the product isn’t deceptive and misleading and is in accordance with applicable German regulatory framework and code of conduct. Provide strategic input and guidance on regulatory affairs matters, including understanding the collaboration between global and local markets for Pharmaceutical promotional materials and associated review workflow for repurposing content, understanding regulatory submission guidelines, filing, negotiations, and amendments, which includes obtaining, assessing and summarizing scientific and other technical information specific for German market Requirements A medical or scientific degree, preferably with a doctorate 4-6 years of pharmaceutical industry experience and 1-2 years of professional experience as Information Officer in a pharmaceutical company Strong scientific acumen and ability to grasp complex therapeutic areas. Experience in dealing with the requirements of the AMG, HWG and UWG and their practical implementation regarding the creation and approval of packaging, advertising materials and non-advertising materials Ability to analyze complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders High communicative competence, confident demeanor, work independently as well as collaboratively Experience in working with cross-functional teams to work out constructive solutions to complex issues Good knowledge of German and English as well as extensive knowledge of MS Office Preferably have experience of working with Promotional Material review Platform like Veeva/Aprimo etc. #J-18808-Ljbffr Nityo Infotech