Role: Senior / Principal Regulatory Writer Business Unit: Bioscript Regulatory Writing
Location: UK (Hybrid or UK remote)
Established in 2005, Bioscript Group is formed from multiple, specialist businesses to support our global pharmaceutical clients; we provide multidisciplinary expertise to help our clients navigate critical decisions at key points in the product lifecycle.
Our scientific and strategic expertise help our clients make better decisions. We provide medical communication services, market access consulting and regulatory writing support with deep domain expertise to effectively navigate complex disease areas.
We are hiring for both Senior Regulatory Writer (SRW) and Principal Regulatory Writer (PRW) positions. This is a fantastic opportunity to join our friendly and supportive team and lead the development of high-quality regulatory documents. You will work closely with our clients and internal teams, providing technical and scientific leadership, and ensuring the delivery of clear, accurate, well-written documents.
Lead and motivate regulatory writing team members, adhering to company policies and procedures. Coach and mentor more junior team members, providing support and guidance on client and project-related issues
Be the point of contact for specific project deliverables, managing the technical and scientific aspects of leadership of designated client accounts/teams
Take responsibility for the delivery of multiple projects across client accounts, ensuring high-quality work that meets the project/client brief, timelines, and budget
Track and manage project scope in collaboration with the Project Management team, demonstrating a sound understanding of budgets
Support development of the regulatory writing training programme, as appropriate
Be a key source of account, product, or therapy area expertise to clients and colleagues
Advise on regulatory writing processes and strategy, document quality process, client procedures, and best practice for projects
Support the Project Management team with development or review of budgets against project specifications, if required
Strong technical and scientific skills with experience in developing high-quality regulatory documents
Excellent communication skills and the ability to coach and mentor junior team members, providing support and guidance on client and project-related issues
Ability to manage multiple projects and deliver high-quality work within deadlines, ensuring the production of clear, accurate, and grammatically correct written work
25 days holiday + bank holidays + winter shutdown + holiday purchase scheme
~ Enhanced maternity, paternity and adoption leave
~ Bonus day off to be spent giving back to the community
~ Life Insurance and Critical Illness cover
~ Private Medical Insurance (Vitality for UK based colleagues)
~ Health cash plan or wellbeing allowance
~ International Employee Assistance Program