Director CMC Writing
Director CMC Writing
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Salary Not Disclosed
1 Vacancy
Job Description
The Role
In this role you will oversee the delivery of clear highquality and timely communication of strategic and technical CMC positions to global Health Authorities by facilitating alignment of diverse technical content with global regulatory requirements optimizing authoring tools and processes and driving continuous improvements in technical documentation.
Heres What Youll Do
Serve as a primary CMC technical writing consultant reviewer and editor for key strategic documents working with subject matter experts (SMEs) to ensure clarity accuracy and regulatory alignment prior to submission.
Implement metrics to assess document quality and effectiveness.
Introduce best practices for authoring and review of CMC documents to drive continuous improvement against document quality metrics efficiency targets and phaseappropriate expectations.
Champion the adoption and integration of digital solutions including artificial intelligence (AI) to enhance efficiency readability and document consistency across the product portfolio.
Manage the internal communication and lifecycle of key CMC strategic positions ensuring stakeholders have access the current and historical state of information and decisions.
Create and deliver technical writing curricula for authors and reviewers as part of ongoing SME skill development.
Additional duties as may be assigned from time to time
Heres What Youll Need Basic Qualifications)
BS or MS with 15 to 20 years of relevant industry experience or PhD with 10 to 15 years of relevant experience in CMC technical development (e.g. process or analytical development) and technical writing for regulatory submissions (e.g. INDs BLAs).
Heres What Youll Bring to the Table (Preferred Qualifications)
Extensive experience authoring and reviewing CMC sections for regulatory filings and deep understanding of the interpretation and application of regulatory guidance (e.g. ICH).
Demonstrated ability to translate complex technical data and strategies into clear and compelling narrative aligned with regulator expectations and guidance.
Significant prior experience both as a technical subject matter expert and as a dedicated CMC technical writer or manager of a CMC technical writers.
Exceptional written and verbal communication skills adept at conveying complex technical concepts and proactively identifying risk and addressing challenges.
reach this level.
Proven matrix leadership capabilities to effectively navigate complex crossfunctional environments.
A high standard and wellarticulated vision of what excellence looks like in CMC technical writing for regulatory submissions and a strong passion to educate and coach authors to
Experience in development of technical writing training curricula.
Passion for innovation particularly leveraging AI and emerging technologies to transform documentation processes.
A desire to make an impact as part of a highgrowth transformational company that is Bold Relentless Curious and Collaborative.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific 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 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 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 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 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.
Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 . (EEO Employer)
#LIKP1Required Experience:
Director
Employment Type
Full-Time
