Sr. Analyst, Medical Writing, AI-assisted Operations

Sr. Analyst, Medical Writing, AI-assisted Operations About the vacancy

• Regulatory Affairs
• Regulatory compliance
• Submissions
• Clinical R&D
• Medical Writing
• Staff
• Public Affairs
• IT
• Operations (IT)
• AI & Machine Learning
• Enterprise Applications & Systems
• Sales
• Communication

Permanent Full time
2340 Beerse, Belgium

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.

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.
• Ability to function in a team environment.
• 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)

Remote work is a possibility.

We only accept applicants who are eligible to work in the EU.

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 Med Tech, 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.

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