Associate Director, Medical Writing

Cambridge, MA, United States

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Associate Director, Medical Writing

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Associate Director, Medical Writing Cambridge, Massachusetts

Job Description The Role:

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.

Here’s What You’ll Do:

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.

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

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.

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

• D iscretionary 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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people  are the driving force behind our scientific progress and our culture.  Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected] . (EEO/AAP Employer)

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Job Insights Based on previously hired candidates

Popular Skills of Previous Hires Clinical Documentation

Biotechnology

Clinical Development

Job titles of previous hires Medical Writer

Manager Regulatory Affairs

Clinical Research Manager

Adjunct Associate Professor

Senior Scientist

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Moderna Therapeutics

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Takeda

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Sheryl Littmann Associate Director Medical Writing

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Executive Director Medical Writing and Clinical Trial Transparency

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Clayton Neumeier Associate Director Medical Writing

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Hikaru Taniguchi Associate Director Medical Writing

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