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Senior Medical Writer

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Senior Medical Writer

ICON plc

• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity • Collaborate with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development • Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards • Mentor and train junior medical writers, fostering a culture of excellence and professional growth • Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs • Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

Job Requirements

  • A bachelor's degree in life sciences, pharmacy, or a related discipline
  • Significant experience in medical writing, particularly in regulatory submissions and clinical documentation
  • Strong understanding of regulatory requirements and industry standards for clinical writing
  • Exceptional writing and editing skills, with a keen eye for detail and clarity
  • Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

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