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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 hybrid work, 25 days holiday, enhanced leave, and health perks like private medical insurance.
- 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: Opportunities for mentorship and career development within a supportive environment.
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.
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. Engaging in conversations on platforms like LinkedIn can provide insights into the company culture and expectations, which can be invaluable during the interview process.
✨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. Highlighting these experiences will illustrate your fit for the role and your capability to lead teams effectively.
✨Tip Number 4
Showcase your mentoring skills by preparing examples of how you've supported junior team members in the past. This aligns with the responsibilities of the role and demonstrates your leadership potential, which is crucial for both Senior and Principal Regulatory Writer positions.
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. Make sure you understand the key responsibilities and required skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in regulatory writing and any leadership roles you've held. Use specific examples that demonstrate your ability to manage projects and mentor junior team members.
Showcase Communication Skills: Since excellent communication is crucial for this role, provide examples of how you've effectively communicated complex scientific information in your previous positions. This could include writing high-quality regulatory documents or leading discussions with clients.
Tailor Your Application: Customise your CV and cover letter to reflect the values and culture of Bioscript Group. Mention your proactive approach to knowledge sharing and team development, as these are important aspects of the role.
How to prepare for a job interview at Bioscript Group
✨Showcase Your Technical Expertise
As a Senior Medical Writer, it's crucial to demonstrate your strong technical and scientific skills. Be prepared to discuss specific regulatory documents you've developed and the processes you followed. Highlight your understanding of complex disease areas and how your expertise can benefit the company.
✨Emphasise Leadership and Mentoring Skills
Since the role involves leading and mentoring junior team members, share examples of how you've successfully coached others in previous positions. Discuss your approach to motivating teams and ensuring high-quality work, as this will show your capability to manage and inspire others.
✨Prepare for Project Management Questions
Expect questions about managing multiple projects and adhering to budgets. Be ready to explain your project management strategies, including how you track project scope and ensure timely delivery. Providing concrete examples of past successes will strengthen your case.
✨Demonstrate a Proactive Knowledge Sharing Attitude
The company values knowledge transfer across teams, so be prepared to discuss how you've shared your expertise in the past. Talk about any training programmes you've developed or contributed to, and how you encourage collaboration among team members.
