Scientist II, Clinical Regulatory Writing

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

📋 Description

• Create, review, and refine clinical regulatory documents, focusing primarily on Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and other related clinical development materials.

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

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

• Integrate feedback from reviewers and oversee version control among multiple stakeholders.

• Track project timelines and guarantee timely and budget-conscious project delivery.

• Contribute to the formation of Cardinal Health's inaugural medical writing team in Ireland and help establish innovative working practices.

⛳️ Requirements

• A Bachelor's or Master's degree in a life science field (e.g., biology, pharmacology, or biochemistry).

• 2-3 years of experience in clinical regulatory writing within the pharmaceutical, biotechnology, or CRO sectors.

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

• Capability to comprehend clinical trial data, methodologies, and intricate research.

• Outstanding writing, editing, and proofreading abilities.

• Skillful in working both independently and collaboratively within a team.

• Ability to perform under pressure and meet demanding deadlines.

• Strong interpersonal skills.

• Proficiency in English is required.

• Familiarity with document management tools such as Veeva and MS Office.

🏝️ Benefits

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

• An inclusive workplace that appreciates diversity in thought, experience, and background.

• Equal Opportunity employer.