Senior Medical Writer - United Kingdom - Bioscript Group

Bioscript Group United Kingdom

1 week ago

Description

Senior/Principal Regulatory Writer Role

Bioscript Regulatory Writing Business Unit

About Us

We are a multidisciplinary expertise provider, established in 2005. We support global pharmaceutical clients with critical decision-making at key points in the product lifecycle.

Our scientific and strategic expertise help our clients navigate complex disease areas, providing medical communication services, market access consulting, and regulatory writing support.

The Opportunity

We are hiring for Senior Regulatory Writer (SRW) and Principal Regulatory Writer (PRW) positions. This is an excellent opportunity to lead the development of high-quality regulatory documents, working closely with clients and internal teams.

You will provide technical and scientific leadership, ensuring the delivery of clear, accurate, well-written documents.

Key Responsibilities

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.
Manage the technical and scientific aspects of designated client accounts/teams, serving as the point of contact for specific project deliverables.
Ensure the delivery of multiple projects across client accounts, meeting project/client briefs, timelines, and quality standards.
Track and manage project scope in collaboration with the Project Management team, demonstrating a sound understanding of budgets and project requirements.
Share knowledge and experience to support the transfer of knowledge across the team, promoting a culture of continuous learning and improvement.
Support the 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, leveraging your expertise to drive success.
Serve as a key source of account, product, or therapy area expertise to clients and colleagues, providing guidance and support.
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 that foster a collaborative and inclusive work environment.
Support the Project Management team with budget development and review, ensuring alignment with project specifications.
Contribute to ongoing recruitment programmes, assisting with candidate assessment and the interview process, if required.

About You

You have strong technical and scientific skills, with experience in developing high-quality regulatory documents.
You possess excellent communication skills, with the ability to coach and mentor junior team members, providing support and guidance on client and project-related issues.
You can manage multiple projects and deliver high-quality work within deadlines, ensuring the production of clear, accurate, and grammatically correct written work.
You have a proactive approach to sharing knowledge and supporting team development, contributing to the transfer of knowledge across the team.

Our People

We treat everyone as individuals and provide opportunities to develop your skills and career around our disciplines.

Benefits

A salary that 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.

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