|The Medical Advisor is a therapy area/product medical expert, and serves to advance the medical and scientific objectives of the company. The Medical Advisor is responsible for developing and implementing local TA/product medical affairs strategies, and planning and executing medical affairs activities: e.g. event preparation, material generation and review, training, expert insight generation. The Medical Advisor is responsible for external expert outreach and scientific dialogue, and partnering cross functionally internally to support organisational objectives from a Medical perspective, while operating effectively within an increasingly compliance-driven environment.
1. Scientific dialogue and exchange with prioritized stakeholders. Develop and foster credible peer-to-peer relationships with medical experts and key opinion leaders. Present scientific and medical infor-mation effectively before large and small audiences, and facilitate medical dialogue.
2. Tailor medical materials provided from Global, for stakeholder engagement and events, to local needs, and ensure compliance with local requirements.
3. Plan, coordinate and oversee local medical advisory boards. Plan and execute scientific stand-alone and other scientific CME meetings.
4. Develop, prepare, and strive to implement tactical therapeutic area, and product specific medical and publication plans in alignment with global and local medical strategy.
5. Analyze pharmacokinetic data. Search, analyze and evaluate literature articles. Interpret, discuss and present medical and safety data related to several therapeutic areas. Execute selected modules for on-going training of medical and non-medical personnel.
6. Provide medical expertise in the review of adverse events locally and contribute to global pharmacovigi-lance activities including design of local POP programs and execution of local RMPs.
7. Provide solid medical/scientific writing, creating summaries of clinical data, preparation of medical re-ports and other documents for submission to health authorities in support of marketing applications or in response to clinical or pharmacovigilance queries. Provide local medical input into core value dossiers, as needed.
8. Provide medical input into, and review of safety label update submissions to MoH, and creation of local labelling (PI & PIL) for new marketing authorisation applications.
9. Foster collaboration and provide medical insights to cross functional groups – compliance, PV,
regulatory, market access, QA, etc.
10. Assess and approve all promotional materials ensuring compliance with local regulations and company requirements.
11. Provide insights into, and preparation of SP3 requests associated with local medical activities.
12. Provide timeous, up-to-date and relevant medical information on company’s products and related thera-peutic areas to internal and external customers. Be the scientific expert on relevant therapeutic areas and products within the portfolio.
13. Provide medical input into local studies including interventional studies, non-interventional studies, investi-gator initiated studies, HEORs, PASS/phase IV studies, where applicable.
14. Provide medical support as required for the export markets, and keep abreast of the regulations and re-quirements of these countries as pertains to medical activities.
15. Maintain close collaboration and communication with Compliance, and Global Medical Office to ensure alignment on all local medical activities.
16. Develop modular training curriculum on allocated therapeutic areas.
17. Train salesforce to deliver the training curriculum at highest standard.
Reporting: To the Medical/Pharmaceutical Affairs side of the organization; Typically Head of Medical/ Pharmaceutical Affairs function
Location: This function is typically office based, with some time being spent as field based. This is subject to local needs, and the discretion of the local head of the Medical/Pharmaceutical Affairs function.
Degree in Health Sciences, or other relevant scientific discipline. Master’s degree (e.g. MPharm, MSc or MBA) would be advantageous.
• Experience in developing and maintaining expert knowledge for the assigned therapeutic area
• A minimum of 2-3 years working in a clinical or pharmaceutical Medical environment
• Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company
• Ability to comprehensively learn about new subject areas and environments
• Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with external experts, physicians and other healthcare decision makers
Fluent in English, both written and spoken
• Product Knowledge
• Translating scientific or clinical data into high quality medical information
• Competent in delivering medical / scientific presentations
• Project management skills
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues; ensures compliance obligations are met across all areas of responsibility.
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins;
responsiveness and flexibility. Excellent team playing and communication skills; strong sense of ownership and accountability
• Solid knowledge of the pharmaceutical environment, drug development process, and the role of Medical Affairs
• Clinical and scientific knowledge of relevant therapeutic areas
• Comprehensive understanding of compliance topics
• Leadership, management and planning skills
• Understanding of commercial principles including market access
Please email your CV to Vicki at firstname.lastname@example.org