Description
The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Moderna’s medical writing team but will lead the charge in delivering high-quality clinical and regulatory writing. From masterminding the planning and coordination to spearheading the delivery of final drafts, your role of Associate Director of Medical Writing will be pivotal. They will be the linchpin connecting the clinical development team, understanding and translating how their work shapes 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.
Roles and Responsibilities
- Functional Knowledge: Possess specialized depth and breadth of knowledge for managing medical writing and regulatory writing within a clinical development program.
- Document Planning and Project Management: Coordinate and oversee the planning, writing, editing, and review of clinical and regulatory documents.
- Cross-functional Collaboration: Work closely with the clinical development team and other departments to ensure alignment and coherence of documents.
- Regulatory Compliance: Ensure that all documents comply with regulatory guidelines and standards.
- Data Interpretation: Understand and interpret complex clinical data and other scientific information.
- Quality Control: Establish and maintain processes to ensure the quality of documents.
- Document Updates: Regularly update and maintain all clinical and regulatory documents.
- Problem Solving: Lead others to solve complex problems using multiple sources of information; use sophisticated analytical thought to exercise judgment and identify solutions.
- Impact on the Team: Guided by functional plans, achieve end results and contribute to policy development and planning.
- Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.
- Line Management: Manage performance, develop talent, and allocate resources to ensure the successful execution of the department’s medical writing strategy.
Qualification and Experience
- Education and Years of Experience: Advanced degree (preferred) with approximately 7 years of relevant experience OR bachelor’s degree with approximately 12 years of relevant experience.
- Interpersonal Skills: Excellent interpersonal skills to effectively communicate and collaborate with all levels of the organization.
- Leadership Skills: Ability to lead cross-functional projects or programs; manage external vendors.
- Business Expertise: Understanding of the business aspects of biotechnology and the ability to contribute to strategic planning. Knowledge of external market and regulatory factors that may impact medical writing; ability to apply best practices to improve processes and services.
- Communication Skills: Excellent written and verbal communication skills, with the ability to communicate difficult concepts and persuades others to adopt a different point of view.
- 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 standard industry software and database systems.