Manager Medical Writing Delivery and Excellence
Manager Medical Writing Delivery and Excellence
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Job Description
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.
Modernas commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients lives worldwide.
Modernas mission is to establish a leadingedge research development and manufacturing facility at Harwell as part of a longterm commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic NHS and government partners across the UK. Were looking for global experts eager to join us in this endeavor contributing to a future where access to lifesaving vaccines is a reality for all.
Heres What Youll Do:
Your key responsibilities will be:
Lead the development coordination and delivery of highquality clinical and regulatory documents ensuring compliance with global standards.
Implement quality control processes to review and refine clinical and regulatory documents before submission.
Ensure alignment with regulatory requirements and industry best practices to support clinical development programs.
Manage external vendors and consultants overseeing contract negotiations and quality assurance of their work.
Develop standardized templates and style guides to maintain consistency in medical writing outputs.
Provide training and mentorship to team members to enhance skills and industry knowledge.
Collaborate with crossfunctional teams ensuring integration of medical writing deliverables with broader project timelines and objectives.
Maintain and oversee the budget for the medical writing department ensuring costeffective resource allocation.
Stay informed of industry trends and regulatory changes to continuously refine medical writing processes and strategies.
Your responsibilities will also include:
Solving problems by identifying and implementing effective solutions applying technical expertise and following best practices.
Contributing to a highperformance culture ensuring clear communication of expectations and addressing challenges proactively.
Supporting ongoing improvements in document management and workflow optimization to increase efficiency and reduce turnaround times.
The key Moderna Mindsets youll need to succeed in the role:
We obsess over learning The field of medical writing is everevolving and staying ahead of regulatory changes best practices and technology advancements will be critical to success. You will bring a strong curiosity and dedication to continuous learning ensuring that Moderna remains at the forefront of medical writing excellence.
We behave like owners As a key contributor to the regulatory and clinical writing process you will take full ownership of projects ensuring the highest quality standards timely delivery and alignment with Modernas broader mission to transform medicine.
Heres What Youll Bring to the Table:
Education and Years of Experience: Advanced degree (preferred) with approximately 3 years of relevant experience OR bachelors degree with approximately 8 years of relevant experience.
Interpersonal Skills: Ability to exchange complex information with others in difficult situations. May be required to guide and convince others.
Leadership Skills: Ability to mentor junior members of the team (if applicable).
Business Expertise: Understanding of how own team integrates with others in accomplishing medical writing objectives.
Quality: Strong commitment to quality and attention to detail.
Technical skills: Proficiency in medical writing software and a strong understanding of the technical aspects of the job (quality control and medical writing). Proficiency in the use of standard industry software and tools.
This role is expected to be in office 70 of the time with flexibility to work from home up to 30.
Moderna offers personalized benefit programs and wellbeing resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to wellbeing
- Free premium access to fitness nutrition and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off including vacation bank holidays volunteer days sabbatical and a discretionary yearend shutdown
- Educational resources
- Savings and investments
- Locationspecific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a worldclass 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 peopleare 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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. 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. Were 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at .
#LIJP1Required Experience:
Manager
Employment Type
Full-Time
