Principal Regulatory Medical Writer
Our client is led by a highly respected entrepreneurial leadership team, with a proven track record in building successful young start‑ups. This young, exciting, rapidly growing clinical‑stage biopharmaceutical business is poised to deliver an important breakthrough for a debilitating condition characterized by chronic unmet need.
Reporting to the Director, Medical and Scientific Communications and working closely with Regulatory Affairs, Clinical Science, Clinical Operations, etc., this key role will significantly contribute to the clinical documentation of clinical development programs and the overall product development pipeline.
You will be part of a small, collaborative team that prides itself on producing high‑quality work in a fast‑paced environment. The role offers the opportunity to contribute to the ongoing growth and success of the business and to be part of its exciting journey.
Responsibilities
Author, review, and independently manage high‑quality clinical documents including protocols, CSRs, complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), and other documents for health authorities (e.g., briefing books, answers to questions); ensure compliance with internal standards and external regulatory guidelines.
Contribute to development of miscellaneous documents requiring medical‑writing oversight (e.g., CEPs, CERs, nonclinical summaries).
Collaborate closely with medical/clinical experts, statisticians, pharmacovigilance, investigators, and other stakeholders during document development.
Contribute to process improvement for medical‑writing activities (e.g., development/update of SOPs, document templates, work instructions) and other cross‑functional initiatives.
Independently develop and manage document timelines.
Review the work of junior and outsourced medical writers and manage projects allocated to outsourced writers.
Contribute to scientific communication activities, e.g., develop/review content for publications such as manuscripts, abstracts, posters, slide decks.
Requirements
Minimum Bachelors degree in Life Sciences or equivalent; advanced degree or equivalent education in life sciences/healthcare highly desirable.
Minimum of 5 years medical‑writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical‑writing processes.
Experience in global regulatory environment and processes (key regulatory bodies, key documents).
Experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred.
Demonstrated ability to define and solve complex problems.
Experience in neuroscience or neurology preferred.
Proven ability to prioritize and manage multiple demands and projects.
Excellent written and oral communication skills within the medical/science area.
Flexible working style with ability to work independently, remotely, and in teams.
For further information on this Principal Regulatory Medical Writer position please contact Larry at The RFT Group on +353 1 2302400 or larry@rftgroup.ie.
Check out all our open jobs on our Recruitment website: https://www.rftgroup.ie
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