RApport - Senior Medical Writer - Flexible Home/Office Based Camberley, UK
We are a specialist international regulatory consultancy which offers a range of services to the pharmaceutical, biotechnological and medical device industries.
Our focus is to strengthen our client’s companies to manage every stage of the development process to provide strategic regulatory affairs support to the pharmaceutical industry. RApport is formed of a team of highly experienced regulatory experts supported by a wide network of allied specialists.
About the Role
The Senior Medical Writer will help build and manage a team of internal and external medical writers to ensure that RApport produced documents meet pharmaceutical industry standard and are of the highest quality.
As the team is being built, hands-on medical writing and internal training will be needed. The Senior Medical Writer will represent RApport at Client meetings and work collaboratively with internal and external stakeholders offering visibility and opportunity to directly contribute to the company’s success. The right candidate will join our Senior Leadership Team and help direct the future of the organisation.
We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, training, and work-life balance. You will receive a competitive salary, the opportunity to develop your skills in an exciting and varied role and work with an ambitious, flexible and highly rewarding company.
The role can be home or office based depending on the candidate. While full time is preferred, flexible working can be arranged for the right candidate.
- Provide support to RApport in building the Medical Writing function including recruitment, training, and mentoring
- Oversee writing assignments of external medical writers
- Build and contribute to process improvements and working groups with cross-functional impact
- Prepare, edit, and finalize protocols, investigator brochures, synopses, regulatory documents, and related clinical documents, such as abstracts, posters, presentations, and manuscripts
- Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Partner with biostatisticians to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
- Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
- Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
- Manage the document review process ensuring conflicting and/or ambiguous comments are appropriately handled.
- Develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio
- Share knowledge with other medical writers (e.g., by giving presentations in team or group meetings)
- Expert knowledge in scientific and/or regulatory writing, including clinical trial reports of all clinical phases and other clinical documents
- Expert knowledge in clinical documents standards and regulatory requirements.
- Willingness to develop good knowledge in assigned therapeutic area and its clinical standards.
- Understanding of the variance in requirements for international writing standards and conventions across regions (e.g. US, EU and Japan)
- Understanding of the business impact of timelines for clinical documents
- Understanding of medical concepts, statistics, pharmacokinetics and pharmacodynamics
- Understanding of the clinical development process and relevant global and local regulatory guidelines
- Ability to independently and effectively communicate complex clinical information in writing for the target audiences
- Ability to comprehend and interpret clinical data
- Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers
- Ability to contribute to process improvements
- Competitive salary
- Permanent full-time position
- 30 vacation days per year (inc. bank holidays)
- Contributory pension scheme
- Commitment to CPD
- Flexible working hours and home office options for a better work-life balance
Qualifications & Skills
- Life Science degree with significant experience in regulatory medical writing in the healthcare industry
- Ability to manage parallel tasks and variable workload
- Strong interpersonal and social skills
- Ability to communicate effectively in international cross-functional teams
- Ability to manage conflicting reviewer’s comments and presentation skills
- Strong scientific and analytical thinking
- Proficiency in word processing and presentation software
- Excellent written and verbal English skills
Good luck with your application. To apply please send your CV and covering letter to email@example.com