Senior Medical Writer

4 days ago

Dublin, Dublin City, Ireland The RFT Group Full time
Overview

Senior Medical Writer — Our client is led by a highly respected entrepreneurial leadership team with a proven track record in building successful start-ups. This young, exciting, rapidly growing clinical-stage biopharmaceutical business is poised to deliver an important breakthrough in a debilitating condition characterized 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 contribute to the documentation of the clinical development program and the overall product development.

You will be part of a small, collaborative team that prides itself on producing high-quality work in a fast-paced environment. This role provides the opportunity to contribute to the ongoing 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), 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 (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 skills within the medical/science field.
  • Flexible working style with ability to work independently, remotely and in teams.
How to apply

For further information on this Senior Medical Writer position please contact Laurentina Kennedy at The RFT Group on or

Job details
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Writing/Editing
Location

Location: Dublin, County Dublin, Ireland

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