Director, Medical Writing

The Role:

Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust understanding of the clinical development landscape. This individual will form an integral part of Moderna’s clinical development team, working closely with them to understand and contribute to the broader objectives of Moderna’s clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.

Here’s What You’ll Do:

• Functional Knowledge: Demonstrate a comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple clinical development programs.

• Document Planning & Project Management: Oversee the planning, writing, and reviewing of clinical and regulatory documents and responses.

• Cross-Functional Collaboration: Work closely with cross-functional teams to ensure timely delivery of high-quality documents.

• Regulatory Compliance: Ensure all documents comply with regulatory guidelines.

• Data Interpretation: Interpret clinical and statistical data to prepare clear, concise documents.

• Quality Control: Implement and oversee quality control processes for medical writing.

• Document Updates: Manage the updates and revisions of documents as required.

• Problem Solving: Direct the resolution of highly complex or unusual business problems applying advanced critical thinking.

• Impact: Guided by functional plans, impact the quality and timeliness of the functional area and results, and develop area plans.

• Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.

• Line Management: Oversee and manage the performance of a high-performing medical writing team, providing guidance, feedback, and mentorship. Responsible for hiring, training, and professional development of team members. Ensure resources are allocated effectively and deadlines are met consistently. Foster a collaborative and positive team environment.

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

• Education: Advanced degree in a scientific or medical discipline.

• Experience: Minimum of 10 years of industry experience, with a focus on medical writing.

• Interpersonal Skills: Ability to influence others internally and/or externally, including colleagues in other departments. Some negotiation with limited impact may be required.

• Leadership Skills: Ability to lead dynamically through senior managers or professionals. Translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for medical writing.

• Business Expertise: Apply market knowledge to drive integrated results across multiple related teams.

• Communication Skills: Excellent written and oral communication skills.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical Skills: Proficiency in MS Office 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 voluntar