Scientist III, Clinical Regulatory Writing

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

📋 Description

• Create, review, and refine clinical regulatory documents, with a focus on Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and associated clinical development materials.

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

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

• Offer scientific and strategic content expertise while providing guidance on regulatory requirements to study and submission teams.

• Work collaboratively with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional teams.

• Contribute to the planning of data analyses and presentation strategies for CSRs, including reviewing Statistical Analysis Plans (SAPs).

• Collaborate with Documentation Specialists and project teams to create final documents, oversee review cycles, integrate feedback, maintain version control, and deliver submission-ready materials.

• Act as a subject matter expert in clinical regulatory writing and ensure adherence to ICH, FDA, EMA, and other global regulatory standards.

⛳️ Requirements

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

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

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

• Strong comprehension of the clinical drug development process and regulatory submission criteria.

• Preferred experience in a pharmaceutical setting or a background in pharmaceutical, clinical, or scientific domains.

• Demonstrated ability to interpret and convey complex clinical and scientific information in a clear, concise, and compliant manner.

• Working familiarity with ICH guidelines, GCP, FDA, EMA, and global regulatory standards.

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

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

• Exceptional written and verbal communication skills in English.

🏝️ Benefits

• Permanent position with opportunities for long-term growth.

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

• Equal Opportunity employer.