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Senior Medical Writer
Our client is led by a highly respected entrepreneurial leadership team, blessed with a proven track record in building successful young start-ups. This young, exciting, rapid growing clinical stage biopharmaceutical business is poised to deliver an important break though in a debilitating condition characterised by chronic unmet need.
Reporting to the Director, Medical and Scientific Communications and working closely with Clinical Science, Clinical Operations, and Regulatory Affairs, this is a key role that will have a significant contribution towards the documentation of the clinical development program and the overall product development.
You will be part of a small and collaborative team which prides itself in producing high-quality work, while working in a fast-paced environment. This role will provide you with the opportunity to contribute to the ongoing success of the business and to be part of its exciting journey.
Key Responsibilities:
* Author, review and/or 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), and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
* Contribute towards the development of other miscellaneous documents requiring medical writing oversight, e.g., CEPs, CERs, nonclinical summaries.
* Collaborate closely with medical/clinical experts, statisticians, pharmacovigilance, investigators, and other relevant stakeholders during document development.
* Contribute to process improvement for medical writing activities (e.g. development/update of SOPs, document templates, work instructions) and other medical writing and cross-functional initiatives.
* Independently develop and manage document timelines.
* May review the work of more junior medical writers and outsourced medical writers and manage medical writing projects allocated to outsourced medical writers.
* May contribute to scientific communication activities, e.g. development/review of content for publications activities, e.g., manuscripts, abstracts, posters, slide decks.
Experience & Qualifications:
* Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is 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 process (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 skill within medical/science area.
* Flexible working style with ability to work independently, remotely and in teams.
For further information on this Senior Medical Writer position please contact Larry O'Leary
at The RFT Group on 01 2302400 / larry@rftgroup.ie.
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