Principal Medical Writer

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

Location

Pennsylvania

Posted

4 days ago

Salary

0

Seniority

Lead

Bachelor DegreeEnglish

Job Description

Principal 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 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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Role Description The Medical Writer - Clinical & HEOR is responsible for developing high-quality, scientifically rigorous, compliant, and engaging content across clinical, medical, and HEOR domains. This role plays a critical role in shaping scientific and value-based narratives that support engagement with diverse stakeholders, including HCPs, payers, IDNs, and health systems. The position requires strong scientific and HEOR literacy, excellent writing skills, and the ability to translate complex clinical, economic, and outcomes data into clear, audience-appropriate materials aligned with therapeutic area and brand objectives. Key Responsibilities - Scientific & Medical Content Development - Author and support complex scientific deliverables including abstracts, posters, manuscripts, oral presentations, publication extenders, response documents, and white papers across therapeutic areas. - Develop Medical Information content such as standard response letters, FAQs, and customer-facing materials. - Draft, edit, and review HEOR-related outputs including value dossiers, slide decks, economic evidence materials, and submissions. - HEOR & Data Interpretation - Conduct comprehensive literature searches and systematic or targeted reviews to support clinical and HEOR narratives. - Partner with health economists, TA researchers, analysts, and statisticians to accurately interpret and translate data from clinical studies, real-world evidence, cost-effectiveness analyses, and budget impact models. - Publications & Congress Support - Support preparation and submission of content for peer-reviewed journals and scientific congresses. - Ensure adherence to publication standards and best practices (e.g., GPP, ICMJE, ISMPP) throughout the content lifecycle. - Compliance, Quality & Standards - Ensure all materials comply with client policies and external regulatory and ethical guidelines (e.g., FDA/EMA, AMA style). - Maintain high standards for accuracy, consistency, and scientific integrity across all deliverables. - Collaboration & Project Management - Collaborate cross-functionally with internal creative, editorial, medical, and strategic partners. - Manage multiple concurrent projects while meeting timelines, quality expectations, and stakeholder needs. - Provide flexible writing support across group initiatives as priorities evolve. Qualifications - PharmD or advanced scientific degree OR Bachelor's degree in life sciences, pharmacy, public health, health economics, or related field with relevant experience. - 1-3+ years of experience in medical writing, medical communications, pharma, consultancy, or related environment; HEOR experience preferred. - Strong scientific literacy with the ability to interpret and synthesize clinical, medical, and economic data. - Excellent writing and editing skills tailored to both scientific and non-scientific audiences. - Knowledge of clinical research processes, publication practices, and regulatory standards. - Strong attention to detail, organization, and ability to work independently within cross-functional teams. - Proficiency with standard authoring and reference tools (e.g., Microsoft Office, EndNote, Adobe Acrobat). Preferred / Nice to Have - Experience with HEOR methodologies (e.g., real-world evidence, cost-effectiveness analyses, budget impact models). - Familiarity with publication and approval platforms (e.g., Veeva Vault, Pubstrat, iEnvision/Datavision, Nubela). - Knowledge of AMA style and global publication guidelines. - Professional certification (e.g., CMPP). - Background working within a pharmaceutical company or healthcare consultancy.

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Job Closed
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