Job Title: Senior Medical Writer
Job Summary
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.