Scientist III, Clinical Regulatory Writing

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Create, review, and refine clinical regulatory documents, including Clinical Study Reports, clinical study protocols, protocol amendments, and other related clinical development materials.

• Assist in the preparation of CTD Module 2 summaries, Clinical Overviews, Investigator Brochures, briefing documents, responses to inquiries from Health Authorities, safety updates, Pediatric Investigation Plans, and additional regulatory submission materials.

• Ensure that all deliverables comply with regulatory standards, internal quality benchmarks, client expectations, and project deadlines.

• Provide scientific and strategic insights to study and submission teams.

• Collaborate with various teams, including Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional stakeholders.

• Assist in planning data analysis and presentation strategies for CSRs, including reviewing Statistical Analysis Plans and associated documentation.

• Work alongside Documentation Specialists and project teams to finalize documents, manage review cycles, integrate feedback, maintain version control, and ensure timely completion.

• Act as a subject matter expert in clinical regulatory writing, ensuring adherence to ICH, FDA, EMA, and other international regulatory guidelines.

⛳️ Requirements

• A Bachelor's, Master's, PharmD, or PhD in Pharmacy, Pharmacology, Life Sciences, Biomedical Sciences, or a similar scientific field.

• A minimum of 4 years of experience in clinical regulatory writing within the pharmaceutical, biotechnology, or CRO sectors.

• Extensive experience in authoring and reviewing regulatory documents, including Clinical Study Reports (CSRs) and protocols.

• A strong grasp of the clinical drug development process and regulatory submission protocols.

• Preferably experience in a pharmaceutical setting or a background in pharmaceutical, clinical, or scientific fields.

• Demonstrated ability to interpret and convey complex clinical and scientific information clearly, concisely, and in compliance with regulations.

• Familiarity with ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements.

• Capability to independently manage multiple writing projects while adhering to tight deadlines.

• Strong skills in stakeholder management and cross-functional collaboration.

• Exceptional written and verbal communication skills in English.

🏝️ Benefits

• Permanent position with opportunities for long-term career growth.

• An inclusive workplace that values diverse perspectives, experiences, and backgrounds.

• Equal Opportunity employer.