Manager, Global Stability Technical Writer

**The Role**:
In addition, the Global Stability Technical Writer will be responsible for supporting Global processes for harmonizing and integration of stability-related activities. Global Stability Technical Writer will also assist during HA Audits and will lead the governance of stability related processes and systems at Global level.

**Here’s What You’ll Do**:
Support effective CMC regulatory submissions for stability related topics (e.g. IND/CTA/BLA/MAA) in timely manner.

Author and Review Stability CTD documents for submission-readiness, to ensure that all submissions conform to health authority guidelines.

Lead the Agency response for Stability related topics and contribute to the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions.

Support the creation and maintenance of CTD submission templates.

Lead and monitor Stability Health Authority commitment ensuring 100% of on time completion.

Create and maintain CTD stability updates plans to ensure submission timelines are met.

Author and review QC Stability relevant procedures to support continuous improvements of systems to improve organization effectiveness and ensure compliance.

Review stability protocols and reports and participates in stability strategy and protocol design to accomplish HA requirements.

Lead stability relevant Change Controls.

Ensures compliance with cGMP and safety requirements.

Reports and communicates stability metrics at Stability committee and to key stakeholders in a timely manner.

**Here’s What You’ll Bring to the Table**:
Bachelor’s degree in relevant scientific discipline with a minimum of 8-10 years Quality Control experience in a Commercial/ Quality Assurance/Quality Control Biotech or Pharma setting with a focus on Stability (preferable in life science or equivalent), including regulatory submissions.

Fluent in written and spoken English.

Deep understanding and experience with EU, US and ICH guidelines and regulations.

Experience in managing stability programs and with stability data trending analysis.

Strong knowledge of cGMP.

Strong experience with CTD format and content regulatory filings.

Outstanding written and oral communication.

Ability to think critically and demonstrate troubleshooting and problem-solving skills.

Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.

Proven ability to lead and manage projects of significant scope and complexity, meeting deliverables and timelines.

Ability to travel up to 20% of the time.

Moderna offers personalized benefit programs and well-being 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 well-being
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 year-end shutdown
Educational resources
Savings and investments
Location-specific 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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna is a smoke-free, alcohol-free and drug-free work environment. #LI-AK2