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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Medical Writer


Reference:SCA014506 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: PhD, Scientist

Medical Writer
Our client, a global pharma company based in Cork, are currently recruiting for a Medical Writer to join their team. As medical writer, you will work with cross functional, multidisciplinary teams to facilitate external scientific publications such as abstracts, posters, manuscripts and presentations, and regulatory documents such as , protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications. This is a contract role with hybrid working.

Responsibilities

  • Plan, write, edit, review, and coordinate the publication of scientific data through peer reviewed journals and forums and/or regulatory documents
  • Facilitate trial development and product registration
  • Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version
  • Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system
  • Build / relationships with vendors / alliance partners
  • Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project
  • Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews
  • Exhibit technical expertise in specific document development
  • Contribute to process improvements, suggesting opportunities where appropriate
  • Provide database and other tool (e.g., document management systems) expertise
  • Work with internal and external speakers to develop and prepare presentations
  • Engage in activities supporting reward and recognition, teambuilding, and diversity
  • Support cross-functional coaching, mentoring, and training



Requirements
  • Bachelor’s Degree
  • Graduate degree with formal research component or in life sciences
  • Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise)
  • Experience in clinical trial process or regulatory activities
  • Experience writing regulatory or clinical trial documents
  • Publication experience
  • Ability to work well independently and as part of a team
  • A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested
  • Demonstrated mastery of written English with experience in medical, or technical writing fields (at least 1 year); professional verbal skills in English
  • Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability
  • Demonstrated project management and time management skills
  • Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
  • Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates)

For more information, please contact Sinéad Cullen on +353879500821 or [email protected]