Medical Scientific Liaison
Posted on Feb 2, 2019 by Darwin Rhodes
Job Duration: 12 Months
Job Location: Dublin, Ireland
• Respond to HCP requests for information and/or data in therapeutic area.
• Meet with customers and researchers on a regular basis through meetings & conferences to:
Ø Gather information and insights on therapy area (Inc. competitor landscape) and their medical and scientific needs.
Ø Exchange disease area knowledge and opinions in order to understand the emerging opinions.
Ø Increase the customers understanding of Janssen products and processes (e.g. clinical data, IIS, clinical trials, compliance processes), according to their expressed interests and needs and to seek their advice on the development of our products.
Ø Manage and maintain positive relationships with Key Opinion Leaders.
Ø Identify Key Opinion Leaders and their areas of clinical/scientific expertise.
Ø To be the point of contact for investigators proposing investigator-initiated studies (IIS) and manage such studies in collaboration with GCO.
• Act as medical reviewers and or medical code signatories with the Irish Business.
• Act as a strategic lead for medical affairs on the Integrated Brand Team and help provide insights from the field to develop medical and IBT strategies.
• Act as medical lead to support the market access team with regards to scoping meetings and rapid review documentation completions and HTA submissions.
• Act as being a key member of the MAST team and provide training for MAST team members.
• Review submissions (e.g. NCPE dossiers) and any other materials produced by OR that require reviewing for data accuracy) in response to requests from Outcomes Research to ensure accuracy and all relevant data is captured.
• Develop Medical Educational strategy for therapeutic brand in collaboration with an external medical education steering committee to ensure Med Ed plans are in line with both the company strategy for the brand and fulfil the educational requirements of the HCP's we collaborate with.
• Meet with the Global Trial Managers within Global Clinical Operations and other Medical Affairs as required to
Ø Provide all relevant information from potential investigators on IIS studies to seek approval for IIS submissions through the PRP and recap process.
Ø Work with GCP to address any issues with ongoing studies
Ø Share best practices
Ø Understand emerging data and publications from the studies and how this might support ROI needs (also network with SKM)
• Maintain awareness of all relevant local country specific differences, for example applicability of the IPHA Code of Practice and the potential impact these differences may have on marketing a product, performing a clinical trial in the IRE or holding an educational event.
• Assist line manager with other general medical affairs & medical education projects as appropriate.
• Develop links with UK and EMEA MAF teams to be able to keep abreast of changes within medical affairs and to ensure the Irish MAF team can leverage initiative from these MAF teams that could bring value locally and could be adopted or adapted by the Irish MAF team
• Actively engage with all internal and external stakeholders to ensure compliance with the necessary Codes of Practice and Laws governing the promotion and sale of medicines within Ireland.
• Review and approval of materials submitted for copy approval.
• Complete annual Drug Safety and HCC Awareness training.
• Complies with designated SOP's for the role.
• Report Adverse Events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain Regulatory compliance.
• Acts in accordance with Johnson & Johnson HCC requirements if interacting with Healthcare Professionals.
• If commissioning contractors or third-party organisations, put contracts in place and provide training so that these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints.
Therapy Area Knowledge
• Conduct literature searches, analyse clinical papers, attend conferences, courses and other such events to be aware of the latest scientific and clinical advances in relevant therapy areas.
• Attend courses and industry meetings, read industry publications and discuss therapy area with colleagues to keep up to date with developments within the pharmaceutical industry and pharmaceutical medicine to ensure they have the capacity to become and maintain their status as therapeutic experts within the business.
Essential Knowledge & Skills:
• BSc/Life Science degree, PhD, Medical Doctor, or Pharmacist
• Deep knowledge of the therapeutic area (heamoncology) AND / OR industry experience in a Medical Scientific Liaison/Scientific Advisor post
• Strength in research and interpretation of medical data
• Relevant work experience, scientific acumen and communication skills in order to be accepted by Leading Specialists in peer-to-peer relationship
• Highly customer focused with an awareness of the importance of business results
• Innovative with the ability to coordinate and drive a complex and changing environment
• Proactive, well organized
• Creative problem solving skills
• Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide