Sr. Manager, Non-Clinical Writing & Submission Specialist
ModernaTX, Inc.

The Role:

Individuals within the Non-Clinical Writing department are part of a highly collaborative team that provide a range of functions supporting nonclinical writing activities for Moderna therapeutics and vaccines. The role will provide support across functional lines within Non-Clinical Sciences (NCS) (e.g., Toxicology, Drug Metabolism & Pharmacokinetics, and Pathology) and are expected to partner heavily with colleagues in Medical Writing, Regulatory Strategy, and Regulatory Operations to deliver high-quality and timely non-clinical modules for submissions to health authorities. The individual will work in collaboration with NCS functional line representatives to support the development of novel drug candidates across all phases of development and will be expected to work on multiple programs, across therapeutic areas and vaccines. Success in this role will require a broad scientific knowledge base, excellent organizational and communications skills, in addition to the ability to edit/author and/or conduct Quality Control (QC) to ensure high quality study reports and regulatory documents. As part of the team, this individual is also expected to support activities to enable authorship and review of manuscripts to support the NCS department's external influencing strategy to educate the external environment on mRNA-based medicines and vaccines. This is a great opportunity for the right candidate to be exposed to many aspects of drug development in a fast paced and exciting environment as Moderna brings novel mRNA-based therapeutics and vaccines to patients.

Here's What You'll Do:

• Collaborate with NCS functional line representatives to author, edit, review, QC, and/or track the non-clinical components of global regulatory submissions and supporting documents, across all therapeutic areas, including but not limited to non-GLP and GLP study reports, INDs, CTA's, BLAs, IBs, and annual updates etc.
  
• Integrate and summarize multiple sources of NCS functional line data (toxicology, pathology, DMPK, pharmacology etc) to generate cohesive submission documents in-line with the projects' regulatory strategy.
  
• Support multifunctional teams by contributing to the authoring, edit, review and/or QC of a variety of other document types including manuscripts, regulatory authority meeting packages etc.
  
• Ensure internal and external adherence to Moderna writing style guides, templates and procedures for non-clinical documents.
  
• Team with NCS functional line representatives to prepare/QC text for addressing Health Authority questions.
  
• Support, and if applicable, assist with developing improved regulatory knowledge management and NCS information management standard practices to enable data-mining and other future analyses
  
• Adhere to agreed-upon timelines for team deliverables and track documents through review cycles. Attend department group meetings as needed to be informed of upcoming timelines and milestones.
  
• Understand the impact of toxicology, drug metabolism & pharmacokinetics, and pathology on other functions within the company such as pharmacology, research, CMC, clinical, etc.
  
• As a SME in the Non-clinical Writing group, you will be expected to develop strong partnerships with colleagues within NCS, and across other internal functions as well as external contractors to support NCS regulatory writing needs.
  
• Identify and surface opportunities for continuous improvement particularly digital/automation solutions to streamline the work we do and evolve NCS to ensure future business and regulatory demands are met.
  

Here's What You'll Bring to the Table:

• Doctorate degree & 7 years of scientific experience OR Master's degree & 10 years of scientific experience OR Bachelor's degree & 15 years of scientific experience in the pharmaceutical/biotechnology sector (e.g. Toxicology, Pathology, DMPK, Biochemistry, Pharmacology other life sciences)
  
• Strong understanding of GLP requirements and ICH/global regulatory requirements, with the ability to summarize and apply them appropriately.
  
• Strong regulatory writing skills, with a minimum of 3 years authoring/contributing to non-clinical submission documents (for the functional areas listed above) and deliver submission documents to global regulatory agencies.
  
• Experience working within Document Management Systems and/or with Regulatory Information Management Software (such as Veeva Vault RIM)
  
• A sense of urgency to your work, to deliver documents on- or ahead of schedule to keep NCS off the critical path.
  
• Experience authoring peer reviewed manuscripts
  
• Experience as QC lead on study reports and/or regulatory submissions, with hands-on experience preparing submission-ready documents preferred.
  
• Ability to lead others and represent the Non-Clinical Writing Group when required on project teams and/or improvement initiatives
  
• Strong Microsoft Office Suite experience required including Microsoft Word, Excel, Teams, and Outlook. Experience working with SmartSheet is a plus.
  
• Must be flexible, adaptable, and able to pivot to changing project priorities and work assignments.
  
• Must have strong interpersonal and intercultural skills, be a team player, be able to self-advocate and willing to work in an environment where individual motivation and accountability are required.
  
• Careful attention to detail and quality are essential.
  
• Excellent scientific written and verbal communication skills required.
  
• Ability to mentor and coach less experienced team members to perform the role to current expectations
  

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 winter shut down
  • 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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