Sr. Analyst, Medical Writing, AI-assisted Operations

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Sr. Analyst, Medical Writing, AI-assisted Operations.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States- Requisition Number: R-049000

Switzerland - Requisition Number: R-050946

United Kingdom- Requisition Number: R-050948

Belgium- Requisition Number: R-050944

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose:

• 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 (eg, 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.

You will be responsible for:

• 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.

Qualifications/Requirements:

Education: Minimum of a university/college degree in a scientific discipline is required. An advanced degree (eg, 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.
• Or