Medical Advisor
Our client is a leading Biopharmaceutical organisation, based in Dublin. They are seeking a Medical Advisor to join an established team for a duration of 12 month contract. The Medical Advisor shall report to the Head of Medical Affairs.
Role/Responsibilities:
• Provide scientific support to internal and external customers in response to clinical interest.
• Deliver the sharing of knowledge to internal stakeholders e.g. through provision of training to help to ensure highest standards of brand/therapy expertise in customer facing teams
• Provide insights to the Integrated Brand Team to help optimise brand/therapy strategy
• Provide insights and clinical scientific expertise to support market access with the HTA process
• Develop the MAF & Medical Educational strategy for the therapy area
• Chair/co-chair medical advisory boards
• Medical Advisors have responsibility as medical code signatories for copy approval
• Complete annual Drug Safety and HCC Awareness training
• Complete annual IPHA code training
• 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
• Decision Making Autonomy
• Signatory of materials submitted for copy approval.
Customer/External Interaction - 55%
• Respond appropriately to unsolicited requests for information and/or data
• Meet with customers and researchers on a regular basis through meetings, conference etc to:
o Gather information and insights on therapy area (Inc. Competitor landscape) and their medical and scientific needs
o Exchange disease area knowledge and opinions in order to understand the emerging opinions
o Increase the customers understanding of our clients 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.
o Manage and maintain positive relationship with Key Opinion Leaders.
o Identify Key Opinion Leaders and their areas of clinical/scientific expertise
• To be the point of contact for investigators proposing investigator initiated studies (IIS) and manage such studies in collaboration with GCO
• Co-ordinate Medical Education Steering Committees with external KOL’s to develop medical education plans for brand and therapy area
• Organisation and participation in Advisory Boards
• Utilise CRM system to track interactions
Internal Collaboration - 25%
• Act as medical reviewers and medical code signatories for relevant materials
• Act as a strategic lead for medical affairs on the IBT 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 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 educational items (e.g. presentations) and deliver training for the business e.g. IBT’s IMM,MAST teams new starters, on an ongoing basis
• Meet with the Global Trial Managers within Global Clinical Operations and other Medical Affairs as required to
a. Provide all relevant information from potential investigators on IIS studies to seek approval for IIS submissions through the PRP and recap process
b. Work with GCP to address any issues with ongoing studies
c. Share best practices
d. Understand emerging data and publications from the studies and how this might support Irish needs (also network with SKM)
• Develop ideas and content for medical education strategy events.
• Assist line manager with other general medical affairs & medical education projects as appropriate
• Consult to the sales teams, for example by helping them to manage individual issues they may be facing, as well as by enhancing their understanding and application of company processes (e.g. UNITAS approval process, PRP process).
• 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 initiatives from these MAF teams that could bring value locally and could be adopted or adapted by the Irish MAF team
Compliance - 5%
• 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
• Complete all relevant SOP’s and Process training assigned to fulfil the Medical Advisor role.
• Review of materials submitted for copy approval and responsible for code sign off of materials as per local copy approval work instruction
• Support Head of Medical Affairs in preparation of cade case materials e.g. Literature searches
Therapy Area Knowledge - 15%
• 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.
• Monitor competitor promotional and scientific activities so as to understand their ongoing strategies, as well as to assess their compliance with the Code of Practice.
• Help identify data gaps and propose mechanisms to fill them.
• Through scientific interactions, gain valuable insights into treatment patterns, and scientific activities and share these with the IBT.
• Understand healthcare environment including HTA process, effects on access to medications, competitive trends, patient pathways.
• Contribute at congresses e.g. Attend medical stand and write assigned summary reports for internal regional knowledge sharing.
• Attend the relevant SKM journal clubs
Qualifications/Experience:
•Scientific masters or PhD, Pharmacist, a minimum of BSc or other life science degree
•Strength in research and interpretation of medical data
•Proven ability to clearly communicate scientific data to both internal and external stakeholders
•Previous MSL/Medical Advisor experience in the Pharmaceutical Industry of minimum 2 years is essential
•Own car & full drivers licence essential