Medical Writer

This growing organization is seeking to expand its medical writing team and fill a Senior Medical Writer role, based in Dublin. Reporting to the Director of Medical and Scientific Communications and working closely with Clinical Science, Clinical Operations, and Regulatory Affairs, this is a key role with significant responsibility for the documentation of the clinical development program and overall product development. You will join a small, collaborative team that prides itself on producing high-quality work in a fast-paced environment. This position offers the opportunity to contribute to the ongoing success of the company and be part of an exciting journey in clinical development.

Key Responsibilities:

• Author, review, and/or independently manage high-quality clinical documents, including protocols, clinical study reports (CSRs), and complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics).
• Ensure that all documentation complies with internal standards and external regulatory guidelines.
• Contribute to the development of other documents requiring medical writing oversight, such as CEPs, CERs, and nonclinical summaries.
• Collaborate closely with medical/clinical experts, statisticians, pharmacovigilance teams, investigators, and other relevant stakeholders during document development.
• Support process improvements for medical writing activities, including development or updates of SOPs, document templates, and work instructions, as well as other medical writing and cross-functional initiatives.
• Independently develop and manage document timelines.
• Review the work of junior or outsourced medical writers and manage projects assigned to external writers as needed.
• Contribute to scientific communication activities, such as developing or reviewing manuscripts, abstracts, posters, and slide decks.

Experience & Qualifications:

• Minimum of a university life sciences degree or equivalent; an advanced degree in life sciences or healthcare is highly desirable.
• At least 5 years of medical writing or other relevant pharmaceutical industry experience, combined with strong scientific and regulatory knowledge and expert understanding of medical writing processes.
• Experience in the global regulatory environment, including familiarity with key regulatory bodies and essential regulatory documents.
• Experience authoring clinical components of regulatory filings (e.g., NDA, BLA, MAA) is highly preferred.
• Demonstrated ability to define and solve complex problems.
• Experience in neuroscience or neurology is preferred.
• Proven ability to prioritize and manage multiple projects and competing demands.
• Excellent written and oral communication skills within the medical/scientific field.
• Fluency in English.
• Flexible working style, with the ability to work independently, remotely, and as part of a team.