Regional Medical Affairs Operations Lead Eu

4 weeks ago

Maidenhead, United Kingdom Seqirus Full time

The Associate Director develops the strategy and implementation surrounding the collection, preparation, and dissemination of medical and scientific information on CSL Seqirus’ products externally to physicians, pharmacists, investigators, health care institutions, agencies, patients and their families and internally to CSL Seqirus partners in multiple countries. This person is responsible for the oversight, supervision, training of medical information vendors as well as the lead for medical information personnel within CSL Seqirus’ partner full-service distributors. This person is responsible for the creation, maintenance, training of all processes and standard operating procedures associated with Medical Information as well as medical information vendors. The incumbent’s portfolio will span all CSL Seqirus pipeline and marketed products in the region.

Responsibilities include:

- Develops and maintains a broad knowledge of medical, scientific and technical information for therapeutic area and product portfolio and is the primary scientific influenza expert for Medical Information. Creates, plans, develops, and reviews key Medical Communication Documents, this includes but is not limited to Scientific Response Documents (SRDs), Frequently Asked Questions (FAQs), content for medical meetings/symposia/Advisory Boards, content for internal Medical Affairs staff training and Data-on-File, ensuring prompt and accurate quality assured documents in alignment with the Global and Regional Medial Affairs scientific messages and strategy. Approximately 1,000 documents each influenza season.
- Is the expert medical reviewer of all medical information documents/materials that go through the review process.
- Partners across functional groups; an expert Medical Information contact and resource to internal colleagues regarding influenza and CSL Seqirus’ product portfolio; provides training and guidance to colleagues, including but not limited to Medical Affairs, 3rd party service providers, commercial sales and customer service teams.
- Develops materials for the implementation of product, therapeutic area, pharmacovigilance and procedural training materials to educate medical information personnel, sales force, MSLs, marketing and others.
- Leads the regional Medical Information function, managing day to day activities and interactions and ensuring processes are in place to respond to inquiries for customers 24/7. Provides ongoing oversight, feedback and review for targets/metrics, inquiry monitoring and written communications to ensure the service is provided to the agreed quality and timelines, including vendor contract and budget monitoring, and management of process for escalated medical inquires.
- Creates a medical information business continuity plan.
- Creates a collaborative work culture between CSL Seqirus and the Medical Information teams within retained medical information vendors and full-service distributor teams.
- Prepares and leads the Medical Information function and contracted medical information 3rd party service providers in audits and regulatory inspections. Leads the resolution of any CAPAs impacting local/regional Medical Affairs departments and medical information 3rd party service providers and completes them within agreed timelines.
- Develops key metrics, targets and supporting strategies for the regional medical information function and service provision. Identifies and analyses appropriate vendors when required. Leads contract negotiations. Analyses reports generated from calls and contacts to identify issues, patterns and trends, and shares the findings with key internal stakeholders.
- These business insights lead to creating new streamlined processes, retraining medical information personnel and enhancing medical communication documents as necessary.
- This includes the creation of a dashboard regarding Regional Medical Information enquiry statistics and metrics summaries for inclusion within management monthly reports.
- Leads in the creation of Medical Information Standard Operating Procedures and Work Instructions, this includes both internal processes and those in place with retained Medical Information, 3rd party service providers. Creates and implements the medical information strategies for launch products including but not limited to documents and trainings. Plans and leads the on-site management of Medical Information Booths at Regional Congresses and Conferences.
- Partners with Pharmacovigilance to ensure that adverse event reporting processes are in place for designated 3rd party service providers and is compliant with local/regional and global safety requirements.
- This includes delivery of training on safety reporting process to 3rd Party Service Providers, including but not limited to Medical Information, Market Research and local-contracted sales teams as well as updating and modifying processes when needed.
- Partners with Quality to ensure that compliant produ

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