Manager X-TA, Regulatory Medical Writing
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About the vacancy
Quality
Validation
Regulatory Affairs
Medical Science Liaison
Medical Writing
Position Details
Location: Leiden, South Holland, Netherlands
Type: Permanent, Full-time
Qualifications: Master’s Degree (WO)
About Your Next Job
Job title: Manager X-TA, Regulatory Medical Writing
Responsibilities
You will be responsible for:
* Preparing and finalizing clinical documents independently across therapeutic areas.
* Leading and managing project teams, including external contractors and cross-functional teams.
* Setting strategies, overseeing work, and guiding junior staff and external collaborators.
* Acting as the primary contact for medical writing activities for assigned programs.
* Participating in meetings, process improvements, and maintaining regulatory knowledge.
* Managing a team of medical writers, setting objectives, and conducting performance reviews.
Skills and Experience
Qualifications:
* University/college degree; Master’s or PhD preferred.
* Minimum 8 years of pharmaceutical/scientific experience, with at least 6 years in medical writing.
* People management experience is a plus.
Additional Requirements:
* Experience in multiple therapeutic areas preferred.
* Excellent communication skills in English.
* Strong leadership, problem-solving, and regulatory knowledge.
Eligibility
Applicants must be eligible to work in the EU.
About Johnson & Johnson
We are committed to healthcare innovation and improving health outcomes worldwide. Learn more at https://www.jnj.com
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