- Director, CMC Writing
- Initial Therapeutics, Inc. in Norwood, Massachusetts, United States
- jobs
- 2 weeks ago
jobs description
The Role
In this role, you will oversee the delivery of clear, high-quality, 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.
Here’s What You’ll 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 phase-appropriate 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 to 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.
Here’s What You’ll 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).
Here’s What You’ll 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 CMC technical writers.
Exceptional written and verbal communication skills, adept at conveying complex technical concepts, and proactively identifying risk and addressing challenges.
Proven matrix leadership capabilities to effectively navigate complex, cross-functional environments.
A high standard and well-articulated vision of what excellence looks like in CMC technical writing for regulatory submissions and a strong passion to educate and coach authors.
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 high-growth, 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. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs.
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
Lifestyle Spending Accounts to personalize your well-being journey.
Family planning and adoption benefits.
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Savings and investment opportunities.
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…