Specialist, Medical Writing

The Role:

The Medical Writer is an essential entry-level position at Moderna. Reporting to the Associate Director or Director of Medical Writing, this role is responsible for providing high-quality clinical and regulatory writing, from planning and coordination through the delivery of final drafts. The Medical Writer will work closely with the clinical development team, ensuring that all content is accurate, well-structured, and compliant with industry standards. The Medical Writer will also be expected to understand and contribute to the broader objectives of the clinical development program, demonstrating an understanding of how their work and the work of related teams impact the overall goals.

Here’s What You’ll Do:

• Functional Knowledge: Has basic conceptual knowledge of theories, practices and procedures within medical writing. With appropriate guidance from senior members of the team, can apply working knowledge of medical writing procedures and clinical development to prepare, write, edit, and review clinical and regulatory documents.

• Document Planning: Participate in project team meetings to provide input regarding deliverables, timelines, resources, and potential challenges.

• Project Management: Manage timelines to maintain communication with stakeholders and ensure timely completion of documents. Plan and facilitate relevant meetings to ensure clear communication throughout the document development lifecycle.

• Cross-Functional Collaboration: Collaborate with cross-functional teams to define the scope and direction of assigned documents.

• Regulatory Compliance: Ensure that all documents are produced in accordance with relevant internal SOPs and external regulatory guidance (FDA, EMA, ICH, etc.).

• Data Interpretation: Interpret and present clinical data and other complex information.

• Quality Control: Conduct thorough quality control checks on medical writing deliverables, ensuring all content is accurate and consistent.

• Document Updates: Update and revise documents as necessary to ensure they remain accurate, clear, and compliant throughout the clinical development process.

• Problem Solving: Use existing procedures to solve standard problems; analyze information and standard practices to make judgments.

• Impact: Maintain a high standard of quality in your own work and work within standardized procedures and practices to achieve objectives and meet deadlines.

Here’s What You’ll Bring to the Table:

• Education and Years of Experience: Advanced degree (preferred) OR bachelor’s degree with approximately 5 years of relevant experience.

• Interpersonal Skills: Strong interpersonal skills with the ability to exchange information and ideas effectively, maintaining tact and diplomacy

• Leadership Skills: Accountable for own contributions.

• Business Expertise: Understanding of how own team contributes to achieving its objectives.

• Communication Skills: Excellent written and verbal communication skills, with the ability to present complex information in a clear and concise manner.

• Quality: Strong attention to detail, with a commitment to high quality and accuracy.

• Technical Skills: Proficiency in Microsoft Office Suite and familiarity with medical writing software.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!