Medical Communications Scientist - Homebased
A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Medical Communications Scientist. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
The Associate Principal MCS provides expert communications leadership to drug projects and drives strategic medical writing, advocating communications excellence and leads the efficient planning and authoring of clinical submissions. The role provides direct support and advice to teams as an expert or through oversight of internal or vendor staff. They are a recognized expert in the field and often the first point of contact for related queries. They prepare clinical regulatory documentation and provide support across programme and strategy level. They provide strong partnership with vendor medical writers to ensure delivery to time, cost and quality.
The Associate Principal MCS role is one that has moved on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.
- Lead development of the clinical submission communication strategy for a new product, liaising with senior project staff
- Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported
- Collaborate with the TA Head and MCS authoring team leader to develop resourcing strategies
- Lead a team of authors (internal and external) to deliver clinical contribution to a submission
- Ensure alignment of clinical submission documents with the proposed prescribing information
- Represent Medical Communication Science on the high-level, cross-functional submission team
- Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)
- Develop and implement new best practices in communication and submission development
- Train and develop less experienced Medical Communication Science staff
Skills and Requirements:
- Bachelor's degree in the life sciences,
- Minimum of two years' experience within the pharmaceutical/medical industry/CRO
- Broad working knowledge of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions.
- Ability to work well with vendors
- Comprehensive knowledge of current regulatory guidelines relating to regulatory communications.
- Excellent communication skills.
- Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working.
- Flexibility in adapting to changing circumstances or new information.
- Contribute to the development of the discipline internally and stay well informed about the external discipline
- May act as a global lead, authoring complex documents, coordinating authoring teams to deliver in line with project strategy, ensuring quality and efficiency in delivery, establishing communication standards and best practice within a project team
- Willingness to undertake domestic and international travel as required by the project.
- MSc or PhD in the life sciences.
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 call George Watson on + 13368428682 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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