Sr. Specialist, Clinical Trial Transparency & Disclosure

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Education: A Bachelor’s degree in a life sciences field; an advanced degree is preferred.
Years of Experience: 1 to 3 years of CTTD or other relevant experience.
Industry Experience: Demonstrated working knowledge of CTTD procedures and clinical development.
Interpersonal Skills: Ability to explain complex information to others in straightforward situations.
Leadership Skills: Ability to provide informal guidance to junior team members or vendors.
Business Expertise: Understanding of how individual and team works closely with related teams to meet the broader objectives of a clinical development program.
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 disclosure software and tools.
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

THE ROLE:

The Senior Specialist CTTD is an essential position at Moderna. Reporting to the Associate Director or Director of CTTD, this role is responsible for providing high-quality clinical and regulatory submissions, from planning and coordination through the delivery of final drafts. The Senior specialist will work closely with the clinical development team, ensuring that all content is accurate, well-structured, and compliant with industry standards. The senior specialist will also be expected to understand and contribute to the broader objectives of the clinical development programs, 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: Apply expanded conceptual knowledge of CTTD 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 disclosure deliverables, ensuring all content is accurate and consistent.
Disclosure Updates: Update and revise studies as necessary to ensure they remain accurate, clear, and compliant throughout the clinical development process.
Problem Solving: Solve problems in straightforward situations; analyzes possible solutions using technical experience and judgment.
Impact: Impact quality of own work and the work of others on the team; work within guidelines and policies.