Regulatory Writing Specialist (Clinical)

Med Communications International; Lisboa; À distance; EUR 50 000 - 75 000; Plein temps

Résumé du poste

Med Communications International is seeking a Regulatory Writing Specialist (Clinical) with 3+ years of hands-on pharmaceutical regulatory writing experience. The role involves authoring CSRs, clinical protocols, IBs, and CTD Module 2 documents, plus coordinating client-facing projects and QC reviews.

The position supports regulatory submissions (IND/NDA/BLA/MAA), nonclinical writing, and collaboration with cross-functional teams. Remote - Europe.

Qualifications

• 3+ years hands-on pharmaceutical regulatory writing experience with substantive document authorship.
• Direct authorship of multiple regulatory documents and client-facing project management experience.
• Experience with regulatory submissions (IND, NDA, BLA, MAA) and CTD Module 2 documents.
• Strong document QC, attention to detail, and scientific writing skills.
• Excellent written English and scientific communication.
• Familiarity with ICH guidelines and FDA/EMA requirements.
• Ability to work independently in a regulatory environment.

Responsabilités

• Author CSR, clinical protocols, IBs, briefing documents and other regulatory reports.
• Prepare and support IND/NDA/BLA/MAA submissions including CTD Module 2 documents.
• Develop nonclinical summaries and CTD Modules 2.4/2.6/4 when applicable.
• Collaborate with internal teams and clients to manage reviews and revisions.
• Conduct QC reviews to ensure accuracy, consistency and compliance.
• Coordinate deliverables to meet project timelines with cross-functional teams.

Connaissances

Regulatory writing

Clinical writing

CSR writing

CTD Modules

Document QC

Project management

English writing

Word formatting

ICH guidelines

Outils

Veeva Vault

SharePoint

PleaseReview

Description du poste

Regulatory Writing Specialist (Clinical)

About the job Regulatory Writing Specialist (Clinical)

Senior Regulatory Writing Specialist

Clinical & Nonclinical | Pharmaceutical Industry

About the Role

We are seeking a Regulatory Writing Specialist with at least 3 years of hands-on pharmaceutical regulatory writing experience, particularly in clinical development and regulatory submissions. The successful candidate will have direct authorship experience across multiple regulatory document types, strong document Quality Control (QC) skills, and the ability to manage client-facing projects and deliverables. Experience in nonclinical or preclinical writing, CMC documentation, and regulatory submission preparation would be an advantage.

Key Responsibilities

• Clinical Regulatory Writing:Author and develop Clinical Study Reports (CSRs), clinical study protocols, Investigator's Brochures (IBs), briefing documents, briefing books, and other clinical regulatory documents.
• Regulatory Submissions:Prepare and support documentation for IND, NDA, BLA, and MAA submissions, including CTD Module 2 documents such as the Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7).
• Nonclinical & Preclinical Writing:Where applicable, develop nonclinical summaries, overviews, and supporting documentation, including CTD Module 2.4, Module 2.6, and Module 4 documents.
• Scientific Documentation:Work with clinical evidence reports, scientific source materials, statistical outputs, and, where required, Chemistry, Manufacturing and Controls (CMC) documentation.
• Document Quality Control:Conduct QC reviews to verify scientific accuracy, consistency, references, data, tables, figures, formatting, and compliance with project-specific requirements.
• Project Management:Liaise with clients and cross-functional teams, manage review comments and document revisions, and coordinate deliverables to meet agreed timelines.

Must-Have Requirements

• At least 3 years of hands-on pharmaceutical regulatory writing experience, with substantive document authorship rather than contribution or review alone.
  

Clinical regulatory writing experience.

• Direct authorship of at least 3 different types of regulatory documents, such as CSRs, clinical protocols, Investigator's Brochures, briefing documents, or CTD Module 2 documents. Client-facing and/or project management experience.
• Practical document QC review experience and excellent attention to detail.
• Advanced Microsoft Word skills, including complex formatting, styles, tracked changes, tables, and document review.
• Excellent written English, scientific communication, and organisational skills.

Optional Requirements

• PhD, PharmD, MD, or another relevant scientific or medical qualification.
  Nonclinical or preclinical regulatory writing experience, particularly CTD Module 2.4, Module 2.6, or Module 4.
• Scientific, pharmaceutical, clinical, or research experience.
• Familiarity with CMC documentation and regulatory submission requirements.
• Experience with Veeva Vault, SharePoint, PleaseReview, or similar document management platforms. Basic understanding of biostatistics and clinical study data interpretation.
• Familiarity with ICH guidelines and FDA or EMA regulatory requirements.

Ideal Candidate

• A detail-oriented regulatory writer who can independently author high-quality clinical regulatory documents, interpret scientific information, perform rigorous QC, and manage client deliverables in a pharmaceutical environment.

Important:
This role requires demonstrable writing experience, not solely document coordination, proofreading, or QC review.
Relevant Job Titles & Keywords
Regulatory Writing Specialist, Regulatory Writer, Clinical Regulatory Writer, Regulatory Medical Writer, Pharmaceutical Medical Writer, Senior Regulatory Writer, Clinical Study Report Writer, CSR Writer, Clinical Protocol Writer, Nonclinical Regulatory Writer, Preclinical Regulatory Writer, CTD Writer, Regulatory Submission Writer.
Core skills:
Regulatory Writing, Clinical Regulatory Writing, Clinical Study Reports (CSR), Clinical Protocols, Investigator's Brochure (IB), CTD Module 2, Module 2.4, Module 2.5, Module 2.6, Module 2.7, Module 4, Module 5, IND, NDA, BLA, MAA, CMC, Document QC, Scientific Writing, Regulatory Submissions, Microsoft Word, Veeva Vault, SharePoint, PleaseReview, ICH Guidelines, FDA, EMA, Biostatistics.

WORK ENVIRONMENT

Remote - Europe

Disclaimer

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.