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