PRA Manager - Denmark
A historic pharmaceutical company is seeking to recruit a PRA Manager to their office in Denmark. The organisation creates informative and engaging online communities that share information in meaningful ways. This vacancy offers an exciting opportunity to work with a leading and innovative pharmaceutical organisation that develops high quality medicines that meet real needs.
The PRA Manager will manage and help deliver company product access dossiers to the Danish Medical Counsel. They will Lead Market Access initiatives across the 5 Danish regions, including the work on guidelines and recommendation lists, and maximize sales/positioning in national tender process.
- To develop a project plan for each submission and ensure that all the required company inputs are delivered on time.
- Manage relationships with selected vendors to deliver submission on time and to budget.
- To organise and chair kick-off meetings and meetings with internal stakeholders aimed to develop and co-ordinate company submissions to MC.
- Manage internal stakeholder list (brand, region and global) and ensure all relevant personnel are consulted at the appropriate time.
- Facilitate/organise company input into relevant clinical guidelines and work with medical around RWD/RWE initiatives
- To work across Therapeutic Areas (TAs) and mini-teams as needed.
- To develop and maintain internal guidelines and processes intended to foster high-quality submissions to Danish authorities
- To be a technical expert on the needs of MC, LMS, AMGROS and their processes.
- To respond to Medicine bodies' requests for comment or information. To act as a focal point for gathering expert comment before replying to the local authorities.
- To foster compliance and reporting of truthful scientific product information in submissions in line with current Danish regulatory and ethical requirements.
- To maximise opportunity for all brands by ensuring payer strategy is aligned with business objectives.
- Apply environmental knowledge and bring the outside in to inform pathways and to anticipate and understand future customer needs.
- Support development of DK value propositions and payer objectives for selected brands.
- Lead PRA aspects of customer planning process for selected brands.
- Collect competitors pricing for previous tender.
- Keep pricing overview.
- To develop a business case for pricing committee.
Skills and Requirements:
- Pharmacy or Life science degree.
- Previous experience of Market Access and writing MC submissions and knowledge of AMGROSs HO processes.
- Experience in medical, drug surveillance, regulatory activities or allied area.
- Experience of developing high quality technical documentation for external agencies.
- Good Knowledge of Danish medical authorities.
- Skilled in using data analytics to make decisions.
- Previous MC or industry experience.
- Worked in multiple therapy areas.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Pontus Larsson at +44 203 319 3030 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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