Senior Medical Writer (Regulatory)
Senior Medical Writer (Regulatory)

Senior Medical Writer (Regulatory)

Full-Time 43200 - 72000 £ / year (est.) Home office (partial)
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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 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 pharmaceutical industry.
  • Qualifications: Strong technical skills in regulatory writing and excellent communication abilities are essential.
  • Other info: Hybrid or remote work options available; perfect for those looking to balance work and study.

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

Seniority level

  • Seniority level

    Mid-Senior level

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Science

  • Industries

    Pharmaceutical Manufacturing

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Senior Medical Writer (Regulatory) employer: Bioscript Group

Bioscript Group is an exceptional employer that prioritises the growth and well-being of its employees, offering a supportive work culture where individual contributions are valued. With a focus on professional development, team collaboration, and a comprehensive benefits package including enhanced leave options and private medical insurance, employees can thrive in their roles while making a meaningful impact in the pharmaceutical industry. The hybrid working model allows for flexibility, making it an attractive opportunity for those seeking a balance between personal and professional life.
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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 more about the company culture and expectations.

✨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 role and the impact of your contributions.

✨Tip Number 4

Showcase your mentoring and coaching experience during discussions. Highlight how you've supported junior team members in their development, as this aligns with the responsibilities of the Senior Medical Writer role at Bioscript Group.

We think you need these skills to ace Senior Medical Writer (Regulatory)

Regulatory Writing Expertise
Technical and Scientific Knowledge
Project Management Skills
Coaching and Mentoring Abilities
Excellent Communication Skills
Attention to Detail
Ability to Manage Multiple Projects
Knowledge of Regulatory Processes
Document Quality Assurance
Team Leadership
Proactive Knowledge Sharing
Client Relationship Management
Budget Management
Strategic Thinking

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 pharmaceutical industry and regulatory processes. Mention specific projects or achievements that align with the responsibilities listed in the job description.

Showcase Communication Skills: Since excellent communication is crucial for this role, provide examples in your application of how you've effectively communicated complex information to various stakeholders. This could include mentoring junior team members or leading project discussions.

Highlight Project Management Experience: Detail your experience managing multiple projects and meeting deadlines. Use specific examples to illustrate how you have tracked project scope and collaborated with teams to ensure high-quality deliverables.

How to prepare for a job interview at Bioscript Group

✨Showcase Your Regulatory 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 a team, share examples of how you've successfully coached junior team members or led projects. This will show your ability to motivate and guide others.

✨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 procedures.

✨Emphasise Communication Skills

Effective communication is key in this role. Be ready to explain how you manage multiple projects while maintaining clear and accurate communication with clients and team members.

Senior Medical Writer (Regulatory)
Bioscript Group
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