Sr. Analyst, Medical Writing, AI-assisted Operations

J&J Family of Companies; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading healthcare company in the UK is seeking an experienced professional to support regulatory medical writing and AI strategy development. The ideal candidate will have significant experience in pharmaceutical writing, strong communication skills, and familiarity with AI technologies. They will participate in cross-functional teams, develop training for end users, and ensure compliance with regulatory standards. This role requires at least 6 years of experience in the pharmaceutical/scientific field and a degree in a scientific discipline.

Qualifications

• Minimum of 6 years of relevant pharmaceutical/scientific experience.
• Minimum of 4 years of clinical/regulatory medical writing experience.
• Familiarity with AI technologies and document automation tools.

Responsibilities

• Support the Regulatory Medical Writing AI business lead in functional AI strategy.
• Participate or lead process working groups.
• Develop and deliver training materials for end users.

Skills

Excellent oral and written communication skills

Attention to detail

Ability to function in a team environment

Strong leadership skills

Demonstrates learning agility

Education

Minimum of a university/college degree in a scientific discipline

Advanced degree (e.g., Masters, PhD, MD)

Tools

Document management systems

AI/GenAI technologies

Document automation tools

Job description

Responsibilities

• Supports the Regulatory Medical Writing AI business lead in delivering the functional AI strategy, including change management support, AI quality improvements, organizing and coordinating user acceptance testing, deployment of upgrades and expansion into new document types.
• Recent experience authoring basic and complex documents within RegMW scope of work, has working knowledge of document landscape and submission dossiers.
• Actively participates in or leads process working groups.
• Provides input into functional tactics/strategy (e.g., writing teams, process working groups).
• Able to work within document management systems and familiar with workflows.
• Able to troubleshoot technical issues and collaborate with IT teams.
• Maintains familiarity with current process for development of clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Assists in rollout and integration of GenAI-enabled authoring and review tools.
• Provides technical and functional support during pilots and full-scale deployments.
• Ensures alignment with regulatory standards and internal SOPs for AI-generated content.
• Supports user acceptance testing and change management activities.
• Develops and delivers training materials for end users.
• Monitors solution performance and gathers feedback for enhancements.
• Maintains current knowledge of emerging AI technologies and regulatory guidance.
• Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Actively participates in or leads process working groups.

Education

Minimum of a university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.

Skills / Experience

• Minimum of 6 years of relevant pharmaceutical/scientific experience is required.
• Minimum of 4 years of relevant clinical/regulatory medical writing experience is required.
• Familiarity with AI/GenAI technologies and document automation tools, including prompting strategies.
• Experience with digital transformation initiatives preferred.

Other

• Excellent oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organizes time well.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross‑functional team members.

Preferred Skills

• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaborating
• Communication
• Copy Editing
• Data Synthesis
• Industry Analysis
• Medical Affairs
• Medical Communications
• Problem Solving
• Process Oriented
• Proofreading
• Quality Standards
• Research Ethics
• Standard Operating Procedure (SOP)

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at https://www.jnj.com