Remote Clinical Regulatory Writer for Submissions

Med Communications International; Almada; Remote; EUR 45,000 - 75,000; Full time

Job summary

Med Communications International is seeking a Regulatory Writing Specialist (Clinical) with 3+ years in pharma regulatory writing, including clinical study reports, protocols, and CTD Module 2 documents. You will manage client-facing projects, perform QC, and contribute to IND/NDA/MAA submissions from a remote Europe location.

The role emphasizes strong English writing, scientific communication, and coordination with cross-functional teams to meet strict timelines and quality standards.

Qualifications

• Minimum 3 years hands-on pharmaceutical regulatory writing experience.
• Direct authorship across multiple regulatory document types.
• Experience with CTD Module 2 documents and CTD submissions.
• Excellent written English and scientific communication skills.
• Client-facing projects and/or project management experience.

Responsibilities

• Author and develop Clinical Study Reports (CSRs), protocols, IBs, briefing documents and other clinical regulatory documents.
• Prepare documentation for IND, NDA, BLA, and MAA submissions including CTD Module 2.
• Develop nonclinical/writeups for CTD Modules 2.4/2.6/4 where applicable.
• Work with clinical evidence, statistics, and CMC docs as needed.
• Conduct QC reviews for accuracy, references, data, tables, and formatting.
• Coordinate deliverables with clients and cross-functional teams to meet timelines.

Skills

Regulatory writing

Clinical Regulatory Writing

CSR writing

Client-facing PM

QC skills

MS Word advanced

Scientific writing

English proficiency

Tools

Veeva Vault

SharePoint

PleaseReview

Microsoft Word

Job description

Med Communications International is seeking a Regulatory Writing Specialist (Clinical) with 3+ years in pharma regulatory writing, including clinical study reports, protocols, and CTD Module 2 documents. You will manage client-facing projects, perform QC, and contribute to IND/NDA/MAA submissions from a remote Europe location.

The role emphasizes strong English writing, scientific communication, and coordination with cross-functional teams to meet strict timelines and quality standards.