Sr. Manager, Clinical Document Process Management

The Role:

The Sr. Manager, Clinical Document Process Management will be responsible for supporting the management and maintenance of the controlled documents within the Clinical Development organization. This role will work closely with the Director, Training and Process Management, the Clinical Compliance and Inspection Readiness team, the Clinical Risk Management Strategy team, and the Quality function to ensure that the organization is in a proactive state of inspection readiness.

The successful candidate will have experience in process, development (authoring/revising) and document management. The individual in this role will have the ability to effectively collaborate across all functional areas in a fast paced and results oriented environment, be detail oriented and have a passion for Clinical Development.

Heres What Youll Do:

• Build and maintain relationships with cross functional teams and relevant internal and external stakeholders including functional heads to support best practices, create, and improve on process and controlled documents

• Oversee the development, optimization and implementation of Clinical Development processes, SOPs, relevant tools, and participate in initiatives for CDO and related functions to enhance our clinical excellence capability that enables Moderna to be successful

• Manage best practice and strategy for business process ownership, development, and work with Clinical Operations Training team to determine relevant and associated training within CDO

• Implement an aligned cross-functional strategy for SOP development, review, and implementation

• Drive SOP and process gap analysis with relevant functions and stakeholders; lead change and implementation on output of gap analysis, as required

• Oversee and provide expert input to procedural documents (ex. SOPs, work instructions, etc.) to ensure a strong GCP compliant foundation for the execution of clinical trials and programs

• Drive a culture of continuous improvement and quality, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality

Heres What Youll Bring to the Table:

• BA/BS required; Applicable experience will be considered in lieu of education; Advanced degree preferred

• Minimum of 7+ years of experience in a clinical research environment within the pharmaceutical and biotech industry

• Experience in leading high performing teams and cross-functional collaboration

• Direct experience in Clinical Operations and SOP development

• Working knowledge of Document Management Systems

• Solid understanding and working knowledge of Contract Research Organizations, third party vendors that support clinical trials, and relationship management

• Strong understanding of appropriate regulations and guidelines (ex. FDA and ICH GCP guidelines) and applicability with clinical trials

• Outstanding verbal and written communication skills

• Ability to manage multiple projects in a fast-paced environment

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

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 year-end shutdown
  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 persons 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.

-