Remote Principal Medical Writer I/II – Regulatory Submissions

Syneos Health; France; On-site; EUR 70,000 - 110,000; Full time

Job summary

Syneos Health is looking for a Principal I/II Medical Writer with clinical and submissions experience to join our regulated environment. This role is fully remote in Italy, the UK, Spain, Poland or Ireland, enabling you to work from home while contributing to high-profile regulatory projects.

You will prepare high-quality medical writing deliverables for regulatory submissions, collaborate with cross-functional teams, and ensure compliance with applicable guidelines.

Qualifications

• Experience in regulatory submissions for pharmaceutical/biotech products.
• Proven ability to produce high-quality medical writing deliverables.
• Strong knowledge of ICH/FDA/EMA guidelines and regulatory expectations.

Responsibilities

• Prepare and coordinate regulatory submission documents.
• Collaborate with cross-functional teams to gather data and ensure accuracy.
• Ensure compliance with applicable regulatory guidelines and timelines.

Skills

Regulatory submissions experience

Medical writing

Education

Advanced life sciences degree

Job description

Syneos Health is looking for a Principal I/II Medical Writer with clinical and submissions experience to join our regulated environment. This role is fully remote in Italy, the UK, Spain, Poland or Ireland, enabling you to work from home while contributing to high-profile regulatory projects.

You will prepare high-quality medical writing deliverables for regulatory submissions, collaborate with cross-functional teams, and ensure compliance with applicable guidelines.