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For Companies At a Glance
- Tasks: Lead a team in creating high-quality regulatory documents for pharmaceutical clients.
- Company: Bioscript Group supports global pharmaceutical clients with expert regulatory writing and medical communication 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 industry.
- 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 43200 - 72000 £ 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.
Senior Medical Writer (Regulatory) employer: Bioscript Group
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 frameworks relevant to the pharmaceutical industry. This knowledge will not only help you in 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 gain insights into what they look for in candidates.
✨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. Be ready to explain your approach to mentoring junior team members as well.
✨Tip Number 4
Research the company culture at Bioscript Group and think about how your values align with theirs. Be prepared to share examples of how you embody these values in your work, particularly in terms of collaboration and knowledge sharing.
We think you need these skills to ace Senior Medical Writer (Regulatory)
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Medical Writer position. Highlight key responsibilities and required skills, ensuring you understand what the company is looking for in a candidate.
Tailor Your CV: Customise your CV to reflect your relevant experience in regulatory writing. Emphasise your technical and scientific skills, as well as any leadership or mentoring roles you've held, to align with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory writing and your ability to manage multiple projects. Mention specific examples of your past work that demonstrate your expertise and how you can contribute to the team.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for grammatical accuracy and clarity. Ensure that your documents are well-structured and free from errors, as attention to detail is crucial in this role.
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 examples of projects you've worked on, the challenges you faced, and how you overcame them.
✨Demonstrate Leadership Skills
Since the role involves leading and mentoring junior team members, be ready to share your experiences in coaching others. Discuss how you've motivated teams in the past and the impact it had on project outcomes.
✨Prepare for Technical Questions
Expect questions related to regulatory writing processes and strategies. Brush up on best practices and be ready to explain how you ensure document quality and adherence to client procedures.
✨Emphasise Your Communication Skills
Effective communication is key in this role. Prepare to discuss how you manage client relationships and collaborate with internal teams. Share examples of how you've successfully navigated complex discussions or resolved conflicts.
