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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 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 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 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. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations, which can be invaluable during your application 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 show your potential employer that you can handle the responsibilities of the role effectively.
✨Tip Number 4
Demonstrate your leadership skills by preparing examples of how you've coached or mentored junior team members in the past. This is particularly important for the Senior and Principal roles, as they require strong guidance capabilities within a team setting.
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 your experience in regulatory writing and any relevant scientific expertise. Use keywords from the job description to demonstrate that you meet the specific requirements of the Senior Medical Writer role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory writing and your ability to lead teams. Mention specific projects or experiences that align with the responsibilities outlined in the job description.
Highlight Leadership Skills: Since the role involves coaching and mentoring junior team members, emphasise your leadership experience. Provide examples of how you've successfully managed projects and supported team development in previous roles.
Proofread Your Application: Before submitting your application, thoroughly proofread all documents to ensure they are free from grammatical errors and typos. Clear and accurate writing is crucial for this position, so make sure your application reflects that standard.
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, the challenges you faced, and how you overcame them. This will demonstrate your technical skills and understanding of the regulatory landscape.
✨Emphasise Leadership and Mentoring Skills
Since the role involves leading and mentoring junior team members, be ready to share examples of how you've successfully coached others in the past. Discuss your approach to leadership and how you foster a collaborative environment within a team.
✨Demonstrate Project Management Abilities
The ability to manage multiple projects is crucial for this position. Prepare to talk about your experience with project management, including how you track progress, manage budgets, and ensure timely delivery of high-quality work.
✨Prepare Questions About Company Culture
Bioscript Group values its people and promotes a supportive culture. Prepare thoughtful questions about their team dynamics, training programmes, and opportunities for professional development. This shows your interest in not just the role, but also in being a part of their community.
