Role: Senior / Principal Regulatory Writer
Business Unit: Bioscript Regulatory Writing
Location: UK (Hybrid or UK remote)
About Us
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.
The Opportunity
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.
Key Responsibilities (SRW and PRW)
- 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
- Proactively share knowledge and experience to support the transfer of knowledge across the team
- Support development of the regulatory writing training programme, as appropriate
- Line management, if consistent with company needs and personal aspirations
Additional PRW Responsibilities
- Lead strategic and high-complexity programs such as submissions
- 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
- Contribute to group discussions, sharing opinions and professional values
- Support the Project Management team with development or review of budgets against project specifications, if required
- Contribute to ongoing recruitment programmes, assisting with candidate assessment and the interview process, if required
About You
- 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
- A proactive approach to sharing knowledge and supporting team development, contributing to the transfer of knowledge across the team
Our people are at the heart of our business
We are focused on delivering the exceptional, not just for our clients, but for our teams too. We treat everyone as individuals and provide opportunities to develop your skills and career around our disciplines.
Our benefits include:
- Salary which aligns with your experience and skillset
- 25 days holiday + bank holidays + winter shutdown + holiday purchase scheme
- Enhanced sick and compassionate leave
- Enhanced maternity, paternity and adoption leave
- Birthday donation to a charity of your choice
- 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
