The purpose of Medical Affairs is to provide and gather scientific insights to/from internal and external stakeholders, and generate data that translates into clear, compelling and strategic scientific exchange and medical education programs. These will impact recommendations, guidelines and medical practice in order to have a positive impact on health.
The Senior Medical Manager (SMM) role is a strategic scientific role within the Medical Affairs team. The purpose of Medical Affairs is to provide and gather scientific insights to/from internal and external stakeholders and support the generation of data that translates into clear, compelling and strategic scientific exchange and medical education programs. These will impact recommendations by NITAGs and strategy to have a positive impact on health.
The role interfaces with other functions within Medical Affairs and across the organisation in Brand and Sales teams, Regulatory, Pharmacovigilance, Communications, Govt Affairs, Market Access, Health Economics and other cross functional teams to ensure collaborative connectivity with these key stakeholders, and a focused medical approach to supporting country and regional business objectives. The SMM, will contribute to the implementation of objectives by leading and executing the medical strategy for one or more products or portfolios under the supervision of the Medical Director.
The SMM will work with the Medical Director and be responsible for developing and leading medical strategy for external engagement, including identifying and developing relationships with key external medical experts in influenza in the United Kingdom and Ireland coordinating advisory boards, medical education programs and scientific communications. The SMM will develop the scientific narrative related to influenza vaccines and gain actionable external insights on this via scientific exchange to identify knowledge gaps in the therapy area, and lead activities to partner with stakeholders to generate real world evidence. The SMM will also work to develop, initiate and execute launch plans.
The SMM will work collaboratively with the marketing team and support them on material development by providing medical input and will complete promotional review and / or certification of materials to ensure they are compliant with the ABPI code of conduct.
As a senior role in the Medical Affairs team a high degree of leadership is required both within Medical Affairs and the broader organisation, demonstrated by leading project and cross-functional teams in the delivery of process improvements and brand associated projects.
The SMM is expected to be flexible and be prepared to be assigned field based medical affairs responsibilities for up to 30% of his time.
Responsibilities include: -
- Develop and maintain in-depth expertise for designated products, including analysis of current literature, opinion and recommendations.
- Be a proactive and strategic member of designated brand/business cross-functional teams.
- Work with marketing and other relevant staff to develop brand strategies and supporting materials for designated products in local and global markets (as required).
- Provision of medical and clinical leadership in product launches, issues management and recall situations. Key member of issues management team.
- Provision of expertise to submissions and presentations to local and global government authorities, where relevant, to achieve registration and/or funding of Seqirus products.
- Build and maintain strong relationships with Seqirus colleagues and relevant medical staff in partner companies to ensure mutual sharing of key product information, issues management and competitive strategies.
- Leadership of medical plan, departmental and cross-functional projects, issues management
- Initiate and/or lead designated departmental and functional and/or cross functional projects.
- Identify issues and collaborate to resolve.
- Lead the review and approval process for funding of study research proposals from external investigators as required.
- Provide input into the medical and clinical appraisal of products evaluated for potential in-licensing for the business as required.
- Act as a spokesperson for medical matters and be a key advocate and subject matter expert for Seqirus products in a range of circumstances e.g. Advisory Boards, seminars, conferences etc.
- Deliver presentations to government groups and KOLs on Seqirus products as part of education-provision to key customers and decision makers.
- Attend relevant conferences and seminars to maintain currency of knowledge and to build and maintain relationships with KOLs and colleagues.
- Liaise with Medical and Scientific Community:
- Provide a point of contact for scientific interaction between external experts / HCP’s and Seqirus.
- Interact responsibly and within MA guidelines with targeted health care professionals, professional associations, health consumer organisations and other key stakeholders.
- Assist with requests for scientific and medical information in a comprehensive, timely and customer focused manner.
- Lead scientific Advisory Board meetings to ensure knowledge transfer, foster key opinion leader (KOL) relationships, ensure scientific understanding and build appropriate advocacy.
- Medical Lead representing Seqirus in Scientific and Medical symposia.
- Lead development of Seqirus sponsored educational programs.
- Facilitate consideration of proposals for collaborative and investigator-initiated studies.
- Lead publication plans including development of submission for and preparation of publications and presentations of study data at Korean medical & scientific meetings and publications.
- Appropriately understand the clinical gaps that would facilitate the development of new therapeutic agents/indications.
- Lead external expert engagement plans and ensure external engagement plans are actively managed for identified external experts.
- Facilitate speaker development and involvement.
- Ensure communications are tracked in appropriate systems.
- Review and approve impactful promotional and educational materials to ensure compliance with local Codes. Provide alternative strategies as appropriate.
- Be able to review (and if possible, certify) material for compliance with the ABPI code of practice.
- Work closely with Medical, Sales and Marketing to develop or improve processes to ensure regulatory and Code of Conduct compliance.
Educations, skills and competencies: -
- Pharmacy or Medical degree; MSc or PhD in relevant Scientific discipline can be considered if an experienced AQP.
- 4+ years’ medical affairs experience with specific medical knowledge and experience in medical affairs and/or medical degree in relevant field.
- Demonstrated ability to lead, influence and motivate a team (evidenced by managing direct reports or medical lead in a cross functional project team)
- Effective delivery of objectives in a complex matrix environment
- Ability to deal with rapid change
- Effective verbal & written communication skills in a cross functional environment
- Attention to detail
- Excellent project management skills
- Proactively owns and drives assigned tasks to completion
- Proactively develops solutions and maximises opportunities ahead of time
- Develops effective contingency plans
- Strong negotiation skills with internal and external stakeholders
- Extensive and proactive commercial awareness with evidenced application to medical strategies
- Excellent customer focus with demonstrated management of customer expectations and anticipating customer needs
- Demonstrated ability to take measured risks with overall positive outcome for the business
- Excellent presentation skills
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
