£55k per year + Benefirs
5 months ago
My client, a niche CRO offering an excellent work environment and career development, are looking for their next Senior Medical Writer.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Acts as lead for assigned writing projects.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develops or supports a variety of documents that include, but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serves as peer reviewer on internal review team providing review comments on draft and final documents
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
- Performs on-line clinical literature searches, as applicable.
- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
- Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Bachelor's degree in Science, Medical Technology, English, or equivalent experience.
- Minimum 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
- A PhD or MSc in Biology or health-related science is desirable and minimum three years + of experience in pharmaceutical medical writing is preferred
- Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
- Effective knowledge of company and sponsor-specific SOPs
- Good written and oral communication skills.
- Superior attention to detail.
- Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Fluent in word processing, flow diagrams and spreadsheets.
- Good working knowledge of personal computer software programs in Windows environment.
- Good communication, interpersonal, and team skills.
- Ability to critically review own work before sending out for internal/external review by team.
- Knowledge of regulations and standards affecting IVDs and Biologics