Ref #: 30246

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 14-Sep-2021


We would ideally be looking for a well-rounded candidate who can adapt to a variety of tasks across various projects and provide good scientific leadership.

The role would be providing medical writing support to clinical development teams, primarily in regional medical affairs but also in established products and other assigned therapeutic areas. The role would support multiple product/disease areas and a variety of document types, so the candidate must demonstrate a flexible approach to scientific writing.

The key roles and responsibilities are outlined below:

• Supports development of clinical documents as required, including but not limited to clinical study reports, protocols and protocol amendments, and regulatory responses.
• Acts as a medical writer on single or multiple assigned projects at a simple to complex level across various therapeutic areas.
• May act as a lead writer on projects, providing internal support and/or oversight to external writers.
• Provides scientific and medical writing support and leadership to assigned product teams.
• Leads project teams in drafting document specifications, medical writing standards
and requirements, and coordination and interpretation of data analysis.
• Schedules and leads peer and team review, and addresses independent quality- control review for assigned projects.

The ideal candidate would have a strong scientific background, preferably with a higher degree (but not essential), and have about 2 years of relevant scientific writing experience. Experience in preparation of clinical documentation, though preferred, is not essential.

Education and Experience Requirements/Qualifications:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience.
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects