Senior Medical Writing Manager
An international biotechnology company is recruiting a Senior Medical Writing Manager to their UK office based in Stevenage. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company.
- Utilise scientific knowledge and medical writing skills to effectively and clearly communicate technical medical plans and results.
- Provide internal medical writing expertise for the planning, authoring, review, and approval of high-quality clinical and regulatory documents.
- Ensure that medical writing deliverables are in accordance with regulations, standards, and guidelines.
- Contribute to outsourcing strategy for medical writing deliverables.
- Provide oversight for outsourced medical writing activities.
- Management of contracts and budget for outsourced medical writing.
- Contribute to process improvement activities, including development and maintenance of medical writing standards & templates.
- Provide input to submission plans, timelines, document content, and dependencies.
Skills and Requirements:
- A Bachelor's degree or equivalent in the Life Sciences as a minimum.
- Proven track record in writing clinical and regulatory documents including, but not limited to protocols, clinical study reports, BLA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
- Ability to Assess trends and patterns in text and statistical data.
- Ability to effectively organise content and messages in clinical reports and summary documents.
- Familiarity with approaches to expedite document preparation such as review tools and automation.
- Experience of vendor contracting, management, and oversight.
- multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Tom Russel at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.