Regulatory Writer

4444

Regulatory

Negotiable

Sussex

•        Under the direction of the appropriate team leader, carry out regulatory and medical writing activities in accordance with the project brief in a timely, accurate and efficient manner, to the highest possible written, scientific and ethical standards.
•        Attendance, where required, at project initiation meetings and taking project briefs; dissemination of the brief to the team members (internal and external) designated to that project.
•        Liaison with freelancers and other external resources as appropriate.
•        Attendance, where required, at project meetings as dictated by the requirements of the client; liaison with the client on all technical aspects of the project; chairing of project meetings with clients, taking minutes and ensuring actions are executed.
•        Full management of the project in a proactive manner, including production of status reports for internal and client reference.
•        Maintaining awareness of current practice in medical writing, medical information techniques, and technology relating to preparation of publications and regulatory documentation.
•        Liaison with all team members to ensure timely QC and completion of documents.
•        Contribution to regular project meetings.
•        Maintaining awareness of current practice in medical writing, medical information techniques, applicable regulatory guidance and technology relating to preparation of regulatory documentation.

Qualifications
•        Graduate scientist in a life science (biology, chemistry, pharmacy, animal or human medicine), preferably at PhD level or equivalent.
Job Knowledge, skills and experience
•        Experience in medical/regulatory writing gained within the pharmaceutical industry or CRO environment with a proven track record in successful submissions
•        Understanding of the principles of drug development and applicable regulatory guidelines
•        Customer-focussed approach – ability to solve problems, instil confidence and gain trust
•        Excellent command of English and strong organisational, communication, literacy and numeracy skills; ability to manage and prioritise multiple tasks, often to tight deadlines
•        Keen eye for detail; ability to assimilate large volumes of data and produce clear, accurate and compelling text in compliance with regulatory requirements
•        High-level awareness of current practice in medical writing, medical information techniques, and technology relating to preparation of regulatory documentation; strong word processing skills.
•        Ability to work in a team and to assume responsibility for project management;

For your prescription to a brighter future please contact us on 020 8941 8090

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