Basic Skills Tutor Salary in Atlanta, GA

The Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patientsHere's What You'll Do:Serve as the biostatistics leader in multiple clinical development teams responsible for determining clinical study strategies and manage teams to deliver results with high quality and on time Champion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programsCollaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data typesOversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analysesPlan, manage, and track biostatistics activities, timelines, and resources and assure operational excellenceFrequently interact with regulatory agencies and effectively address the statistical questions and requests Review and/or author SOPs and/or Work Instructions related to biostatistics practicesCollaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsOversee statistical contractors / consultants and manage / mentor junior team membersHere's What You'll Bring to the Table:PhD (or equivalent degree) with 9+ (for Director) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experience.Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. Experience in Rare Diseases therapeutics clinical development is preferred.Working knowledge of relevant FDA, EU, ICH guidelines and regulations.Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred.Experience working with clinical safety, independent unblinded statistician is preferred. Experience working with CROs, vendors, and relationship management preferred. Outstanding communication skills (verbal and written).Ability to manage multiple projects in a fast-paced environment.Ability to effectively 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince 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 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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 modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-MM1-#LI-Remote

The Role:The Executive Director, CMC Regulatory Affairs will manage a team of experts including individual contributes and one-over managers responsible for regulatory CMC activities through all stages of the lifecycle for product in their portfolio. The team will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Executive Director will be required to oversee the activities of the team, including review and approval of CMC and Quality related agency correspondence and regulatory applications for all the products in their portfolio. The individual will be expected to actively participate in cross-functional governance teams for topics relevant for products in their portfolio. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. The induvial will also actively lead and/or actively participate in cross-functional teams to improve and simplify complex business processes. Effective communication skills will be critical to overall success. The individual will also be responsible for mentoring and development of members of their team. The Executive Director will be based at the Norwood or Cambridge, MA site.Here's What You'll Do:Lead a team to develop/implement effective CMC regulatory strategies for submissions(e.g. IND/CTA/BLA/MAA) and identify regulatory riskProvide strategic advice to manufacturing and quality teams on complex technical and regulatory CMC topicsPartner closely with senior leaders and key stakeholders to help working teams navigate emerging issuesWorks collaboratively with other members of the regulatory organization to ensure alignment on regulatory strategies and priorities are alignedReview documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the companyLead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert levelDevelop regulatory processes and procedures to support CMC components of regulatory submissionsLead and/or actively participate in cross-functional teams to improve and simplify business processSupport the creation and maintenance of CMC submission templatesProvides interpretation of domestic and international regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfullyEffectively manage resources to ensure business priorities are met.Mentor and develop their team. Here's What You'll Bring to the Table:Minimum QualificationsMS/PhD degree in a scientific/engineering discipline10+ years of experience in the pharmaceutical/biotech industry8+ years of experience in Regulatory CMC, including DMF/ASMF submissionsStrong knowledge of current US, EU, and ROW regulationsStrong experience with CTD format and content regulatory filingsExceptional written and oral communicationPreferred QualificationsMS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus8+ years of experience in Biologics focused Regulatory CMCModerna 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince 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 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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 modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-TR1-#LI-Remote

The RoleModerna is seeking a team of experienced Regional Account Managers to support the commercialization of Moderna's groundbreaking vaccine portfolio. In this role, you will be joining Moderna at both an exciting, as well as critical time as we commercialize our respiratory vaccine pipeline.Reporting to a Senior Director, Regional Account Management you be responsible for developing and enhancing customer relationships with largest vaccinators throughout your region. This includes Regional Health Systems, State Awardees/VFC, Federally Qualified Health Centers, Contracting Entities, Physician Groups and Specialty Providers. You will develop expert knowledge of Moderna's respiratory vaccine portfolio/mRNA platform and use this along with your knowledge of strategic customer requirements to expand vaccination rates and achieve account sales targets.To be successful, you must thrive in a fast-paced, team environment and excel at developing high-level customer relationships with the procurement, business development, clinical, operational, trade management, and marketing teams within your region's largest providers of health care services.This role is based remotely.Here's What You'll DoDevelop strategic account plans that will enhance customer relationships, achieve sales targets, facilitate retention and growth within key customers (IDNs, Health Systems, FQHCs, Awardees, Physician Groups, Contracting Entities, etc) to support and oversee successful communication and negotiationAct as the primary point of contact for Moderna for a defined set of accounts, analyzing and understanding sales trends for product sales to each account, achieving defined goals and objectives, developing expert knowledge of the products offered by the company to ensure an excellent understanding of the customer requirements and promoting a mutually beneficial business relationship while adhering to Moderna Core Values and MindsetsWork with your Sr. Director, within channels to establish & execute tactical initiatives reflected in dedicated business plans, which align with the business unit objectives.Analyze account objectives for each product and develop strategic/tactical plans to accomplish brand business objectivesDevelop and maintain contacts within the industry to obtain environmental, competitive, and product-specific informationBuild and maintain long-term relationships within defined customer bases to ensure customer alignment and create a foundation for new businessCollaborate and partner with internal and external stakeholders to enhance Moderna's position in the marketResponsible for cultivating a close relationship with cross functional team colleagues in Medical Affairs, Marketing, Distribution / Logistics, Strategic Partnerships, Customer Service, and Public Affairs departments to implement corporate, operational (shipping/inventory), market access and brand specific strategies and tacticsRepresent Moderna at key trade and customer meetings / conferences.Promote Moderna portfolio of products to key customers that drives differentiation for Moderna and successful long-term business relationshipsCollaborate with appropriate Moderna business teams, marketing, and medical affairs to ensure alignment and full utilization of resources at account level. This includes utilization of marketing materials, execution of in-services, development, and execution of marketing or other service agreementsLiaise with Contracts, Customer Operations, Legal, HR, and Finance to ensure successful outcomes for the responsible channels.Here's What You'll Need (Minimum Qualifications)Bachelor's Degree requiredMinimum 10 years of experience in pharmaceutical/biotech account strategy and account managementHere's What You'll Bring to the Table (Preferred Qualifications)Prior experience in vaccines is highly preferredKnowledge and understanding of product reimbursementDemonstrated prior experience with establishing and consistently meeting or exceeding business development targetsExperience in a startup environment, preferably launching new vaccines or medicinesExperience working with complex Academic Medical Centers & teaching hospitalsWorking Knowledge of capitated and risk-based providers and fundamentals of value-based careDemonstrated track record of building and driving volume and profitable revenue growth with key corporate or private sector accountsAbility to collaborate among a range of key areas (marketing, field team, communications, promotion, physician, trade and consumer channels, pricing and contracting, and/or buyers).Strong portfolio of commercial skills obtained through experience and application with track record of delivery including negotiation, building a financial business case & working within commercial teams.Must be comfortable with ambiguity and a fast-paced, highly dynamic environment that is being defined in real-time. You should be driven and willing to think creatively and pursue new or novel approaches to business and market development. The fast-moving market for vaccines will require a high degree of adaptability and trust building with key accountsExperience leveraging data and digital enablement tools to prioritize opportunities across a dynamic landscape of potential and targeted regional accountsExcellent communication, presentation, collaboration and influencing skills across internal and external stakeholdersA desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeModerna 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince 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 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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 modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -#LI-Remote