Our client is a global, industry-leading provider of regulatory and pharmacovigilance writing, project management and consultancy. They are currently looking for a Regulatory Writer to carry out regulatory and medical writing activities.
Under the direction of the Managing Editor or Senior Regulatory Writer, carry out medical writing activities in a timely, accurate and efficient manner, within budget, to the highest possible written, scientific and ethical standards.
• Accurate and precise interpretation and incorporation of client/author amendments
• Adhere to client’s SOPs and related procedure.
• Attendance, where required, at project initiation meetings and taking project briefs; dissemination of the brief to team members (internal and external) designated to that project.
• Attendance, where required, at further 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.
• Contribution to internal project meetings.
• Assist the Project Manager where required, including production of status reports for internal and client reference.
• Liaison with the Manager, Quality Control to ensure timely completion of documents.
• Maintaining awareness of current regulatory guidance, medical information techniques, and technology relating to regulatory documentation.
• Understanding of current regulatory guidance and ability to produce the range of documents that constitute the client’s offering.
• Ability to produce medical writing and perform science review of the highest standard.
• Ability to communicate with key client personnel in a professional and credible fashion
• Ability to work as part of a team with colleagues across professional, operational and cultural boundaries.
• Excellent organisational skills and ability to work on own initiative.
• Excellent project/time management skills
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