What are the responsibilities and job description for the Specialist, Medical Writing position at Moderna?
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!
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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