Scientist II, Clinical Regulatory Writing

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

📋 Description

• Create, review, and revise clinical regulatory documents, focusing on Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and associated 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 other regulatory submission materials.

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

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

• Track timelines and guarantee that projects are completed punctually and within budget.

• Contribute to the establishment of Cardinal Health's inaugural medical writing team in Ireland and implement new processes and methodologies.

⛳️ Requirements

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

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

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

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

• Outstanding writing, editing, and proofreading abilities.

• Competence to work autonomously as well as 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 (e.g., Veeva, MS Office).

🏝️ Benefits

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

• A welcoming workplace that embraces diverse perspectives, experiences, and backgrounds.

• An Equal Opportunity employer.

• Employees are encouraged to express their true selves every day.