Title: Senior Medical Writer
Location: Cambridge, UK
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it.
As a Senior Medical Writer within our Medical Writing team you will play a pivotal role in developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products as well as developing high-quality clinical abstracts, posters, and manuscripts. You will report to a Director/Associate Director, Medical Writing and work under general/limited supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.
This role can be filled at Senior or Lead Medical Writer level.
If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
Main Duties and Responsibilities
As a Senior Medical Writer you will be responsible for writing/editing clinical regulatory and other supporting documents for assigned studies/indications, and managing the overall development and approval process. You will critically analyse, synthesize, and present complex information and provide QC review support as needed. Your responsibilities will also include writing clinical abstracts, posters, and manuscripts for assigned studies and working with service providers/contractors as needed for delivery of assigned documents.
You will also be involved in:
- Contributing to or assisting in the preparation of document templates and procedures.
- Building cross-functional capabilities by providing writing-related training as needed.
- Supporting continuous improvement within the MW group and using knowledge and experience to improve document quality and process efficiency.
- Promoting adherence of documents to MW standards and processes.
- PhD/PharmD in a scientific discipline, or a Master’s degree with relevant experience.
- Strong experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment. This includes authoring/editing CSRs and other types of clinical regulatory documents (eg, clinical protocols, Investigator’s Brochures) as well as authoring clinical/scientific abstracts, posters, and manuscripts.
- Proficiency in the use of Microsoft Office applications with experience working in electronic document management systems.
- Knowledge of the drug development process and principles of GXP/ICH/CTD and other global standards, with an understanding of the basic strategy for regulatory submissions.
- Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
- Strong written, verbal, and interpersonal communication skills. High attention to detail.
- Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment.
- Background in biologics is nice to have but not essential.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
MedImmune is an equal opportunity employer. MedImmune will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Closing date: 8th March 2018