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For Companies At a Glance
- Tasks: Lead a team to create high-quality regulatory documents for pharmaceutical clients.
- Company: Bioscript Group supports global pharmaceutical clients with expert medical communication and regulatory writing services.
- Benefits: Enjoy 25 days holiday, enhanced leave, private medical insurance, and a bonus day for community service.
- Why this job: Join a friendly team, develop your skills, and make a real impact in the healthcare sector.
- Qualifications: Strong technical skills in regulatory writing and excellent communication abilities are essential.
- Other info: Hybrid or remote work options available, fostering a supportive and inclusive culture.
The predicted salary is between 36000 - 60000 £ per year.
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.
Contact Detail:
Bioscript Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (Regulatory)
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and standards in the pharmaceutical industry. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory writing field, especially those who work at Bioscript Group or similar companies. Attend industry conferences or webinars to make connections and learn about the latest trends and challenges in regulatory writing.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that showcase your ability to manage multiple tasks and deliver high-quality documents under tight deadlines. Highlight your experience in coaching and mentoring junior team members, as this is a key aspect of the role.
✨Tip Number 4
Research Bioscript Group's recent projects and achievements. Being knowledgeable about their work will allow you to tailor your conversation during interviews and show how your skills align with their needs and values.
We think you need these skills to ace Senior Medical Writer (Regulatory)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory writing and showcases your technical and scientific skills. Emphasise any leadership roles or mentoring experiences, as these are key for the Senior Medical Writer position.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your understanding of the role and the company. Mention specific projects or experiences that align with the responsibilities listed in the job description.
Showcase Communication Skills: In your application, provide examples of how you've effectively communicated complex information in previous roles. This is crucial for the role, as excellent communication skills are highlighted as a requirement.
Highlight Team Leadership Experience: If you have experience leading teams or mentoring junior writers, make sure to include this in your application. Discuss how you’ve motivated team members and contributed to their development, as this aligns with the company's focus on team support.
How to prepare for a job interview at Bioscript Group
✨Showcase Your Regulatory Writing Expertise
Make sure to highlight your experience in developing high-quality regulatory documents. Be prepared to discuss specific projects you've worked on and the impact of your contributions.
✨Demonstrate Leadership Skills
Since the role involves leading and mentoring junior team members, share examples of how you've successfully coached others in previous positions. This will show your ability to motivate and guide a team.
✨Prepare for Technical Questions
Expect questions related to regulatory writing processes and strategies. Brush up on best practices and be ready to discuss how you ensure document quality and adherence to client specifications.
✨Emphasise Your Communication Skills
Effective communication is key in this role. Be ready to explain how you convey complex scientific information clearly and accurately, both in writing and verbally, to various stakeholders.
