Medical Writer – Medical Information

Posted 4ds ago

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Job Description

Medical Writer crafting clinical study reports, protocols, and regulatory documents for Thermo Fisher Scientific's pharmaceutical and CRO clients. Supporting scientific communication, quality compliance, and deliverable planning.

Responsibilities:

  • Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
  • Serve as primary author for routine documents such as clinical study reports and study protocols
  • Summarize data from clinical studies
  • Assist with complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
  • Ensure compliance with quality processes and requirements for assigned documents
  • Assist in determining best practices, methods, and techniques for optimal results
  • Assist with program management activities, including developing timelines, budgets, and forecasts for assigned deliverables
  • Represent the department at project launch meetings, review meetings, and project team meetings
  • Collaborate with internal and external clients to support effective and efficient communication and operational excellence

Requirements:

  • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
  • 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
  • Experience working in the pharmaceutical/CRO industry preferred
  • Experience in scientific writing advantageous
  • Solid medical writing skills, including grammatical, editorial, and proofreading skills
  • Ability to interpret and present complex data accurately and concisely
  • Effective administrative, organizational, and planning skills; attention to detail and quality
  • Ability to work on own initiative and effectively within a team
  • Effective oral and written communication skills
  • Good knowledge of regulatory documentation and the drug development process
  • Great judgment and decision-making skills
  • Good computer skills and proficiency with client templates
  • Good knowledge of document management systems and relevant applications, such as Excel and Outlook

Benefits:

  • Variable annual bonus based on company, team, and/or individual performance results
  • National medical and dental plans
  • National vision plan, including health incentive programs
  • Employee assistance and family support programs
  • Commuter benefits
  • Tuition reimbursement
  • At least 120 hours paid time off (PTO)
  • 10 paid holidays annually
  • Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave
  • Accident and life insurance
  • Short- and long-term disability
  • 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) with the opportunity to purchase company stock at a discount
  • Remote work arrangement