Administrative Salary in Norwood, MA

The Project Manager is responsible for:Running Commercial (healthcare/higher education) projects - start to finish - up to $2M Reporting to / working closely with the Project Executive Commuting to project sites and office Upholding company image / professionalism Completing projects on time and within budgetProcessing/approving project invoices & client requisitions on timeMonthly cost to complete/project financial projectionsPositive client feedback/satisfactionEffectively collaborating & communicating with internal/external partiesMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The right candidate has the following qualifications:Minimum of 4+ years experience working as a Commercial Construction project managerHealthcare & Higher Education projects is a plus!Comfortable running projects up to $2M Proficiency in Procore & good computer skillsConstruction related degree

Our client, a technologies company in Norwood, is seeking a Temporary Executive Assistant to cover a medical leave through June. This role is Monday through Friday 9 am - 5 pm and can pay $35-37/hour based on experience. This position demands a dynamic individual who is highly organized, detail-oriented, and capable of handling a wide range of administrative and executive support tasks. The Executive Assistant will act as a gatekeeper and liaison, managing communication flow, scheduling, and ensuring the CEO's day-to-day operations run smoothly. Responsibilities: Calendar Management: Efficiently manage the CEO's calendar, including scheduling appointments, meetings, and conference calls. Prioritize appointments and ensure the CEO's schedule is optimized.Email and Communication Management: Screen and manage incoming emails, phone calls, and correspondence on behalf of the CEO. Respond to or delegate messages as appropriate, ensuring timely and accurate communication.Travel Arrangements: Coordinate domestic and international travel arrangements for the CEO, including flights, accommodations, transportation, and itinerary planning. Anticipate travel needs and address any potential issues proactively.Meeting Coordination: Arrange and prepare materials for executive meetings, including agendas, presentations, and reports. Attend meetings, take minutes, and follow up on action items as necessary.Information Management: Maintain confidentiality and discretion in handling sensitive information and documents. Organize and maintain electronic and paper files, ensuring easy access and retrieval of information.Administrative Support: Provide general administrative support to the CEO, such as drafting correspondence, preparing expense reports, and managing office supplies. Handle special projects and assignments as needed. Ordering supplies and stocking for the office and kitchen will also be required. Relationship Management: Serve as a liaison between the CEO and internal/external stakeholders, including board members, clients, employees, and business partners. Build and maintain strong professional relationships on behalf of the CEO.Problem Solving: Anticipate challenges and proactively identify solutions to ensure the CEO's objectives are met efficiently. Exercise sound judgment in decision-making and problem-solving.Adaptability: Be flexible and adaptable to changing priorities and demands, demonstrating resilience and resourcefulness in a fast-paced environment. Qualifications: Bachelor's degree in business administration, communications, or related field preferred.Proven experience as an executive assistant or similar role, supporting C-level executives.Exceptional organizational and time management skills, with the ability to multitask and prioritize effectively.Strong written and verbal communication skills, with a keen attention to detail.Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) and ZOOM applications.Discretion and confidentiality in handling sensitive information.Professional demeanor, with excellent interpersonal and relationship-building abilities.Ability to work independently with minimal supervision, as well as collaboratively within a team.Willingness to work flexible hours and adapt to changing schedules as needed.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you.Beacon Hill. Employing the Future (TM)

The Role:Moderna is seeking a Manager, Sample Management for the Clinical Biomarker Laboratory to serve as a point of contact to support logistical aspect of clinical specimen testing activities across multiple clinical projects. This position reports to the Associate Director of Lab Operations, part of Moderna's Clinical Biomarkers group.Here's What You'll Do:Lead and participate in bio-specimen accessioning and ordering with our internal groupEstablish robust procedures to ensure shipment and tracking of biospecimen shipment through LIMS and specimen storage and preparation for all biomarker groupsEnsure tracking, delivery and tracking of biospecimen shipment through LIMSManage the specimen storage at the appropriate temperature and location in BiostoragePrepare specimen for technical staff for testing according to schedule and testing plans for the dayRecommendations for the implementation of strategic lab operation objectivesSupport the Lab manager with the implementation of new technical resources to improve on clinical specimen storage through LIMS (RFID system)Lead implementation of new automated platforms and their integration into the Lab operationsManage compliance to regulations and SOPsManage LIMS access for specimen accessioningSupport the implementation of strategic lab operation objectivesMaintain compliance to regulations and SOPsScheduling laboratory and equipment time for staffParticipate to the Laboratory workflow daily, including quality control on instruments, schedule maintenance with vendors upon needsActing as a liaison between leadership staff and key stakeholdersEnsuring that all team members have been trained to use laboratory equipment, software, and supplies safely and efficientlyMaintain clinical biomarker laboratory SOPs directoryActively participate in the cleansing and sanitizing of the lab according to EHS policies and Laboratory SOPsSpecific duties may change depending on the Laboratory growth and type of new instruments and personnel joining the team along the timeOccasionally the job may require overtime work or weekend shift as neededHere's What You'll Bring to the Table:Bachelor's degree in a scientific discipline is requiredMinimum 5 years of relevant sample management experience in CRO, biomedical institution, pharmaceuticalExperience in lab management (LIMS) and clinical specimen management are needed.Ability to oversee multiple aspects of the operations.Previous experience in working in CLIA, GLP or diagnostics regulated laboratory is preferredAttention to detail, organizational ability, judgement, and excellent communication skillModerna 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-

FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.The Billing Group Business Process Specialist role plays a critical function in making sure invoices are sent out timely and accurately. The position will identify and resolve billing issues, both from a customer and a system perspective. The Business Process Specialist will work within a team to process billing in accordance with established policies and procedures. Will also be responsible for updating customer information changes, research and validating client billing data. Provides individual coaching and/or small group instruction to the business end users on new or changed related processes, or to solve process-related problems, as requested. May be called upon to assist with testing the applications used to support document processing and data entry/data processing, and document test results.Ensure invoices are sent out timely and accurately.Manage and produce monthly, annual and ad-hoc reports Triage customer billing issues.Work with internal customers and other departments on billing issues.Identify solutions to reoccurring issues.Bachelor's degree preferredFive+ years of relatable experience in areas such as data entry/data processing, billing or accounting in a business office environment. Prior billing experience a plus but not required. Skills/Knowledge:-Proficiency in Microsoft Office Products-Data entry/data processing and/or transaction processing -High level of technical aptitude-Detailed oriented-Ability to learn new systems-Knowledge of billing processes-Strong analytical/problem-solving and troubleshooting abilities-Excellent communication skills, oral and written-Ability to multi-task, prioritize and organize work in a dynamic, non-routine environmentThe final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM Global's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.#LI-TA1

The Role:The Sr. Manager, Global Regulatory CMC will be support regulatory CMC activities for one or more programs. The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. The Sr. Manager 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 and will be based at the Norwood, MA site.Here's What You'll Do:Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risksProvide guidance for regulatory CMC aspects of product development projectsReview documents for submission-readiness, to ensure that all submissions conform to health authority guidelinesContribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissionsSupport develop regulatory processes and procedures to support CMC components of regulatory submissionsSupport the creation and maintenance of CMC submission templatesProvides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controlsProvides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programsHere's What You'll Bring to the Table:Minimum QualificationsBA/BS degree in a scientific/engineering discipline6+ years of experience in the Pharmaceutical industryKnowledge of current US and EU regulations and cGMPExperience with CTD format and content regulatory filingsExceptional written and oral communicationPreferred QualificationsBS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable8+ years of experience in regulatory in the pharmaceutical/biotech industry4+ years of experience in Regulatory CMC is desirableModerna 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-LG1-

Reporting directly into the Director of HR, this HRIS Manager role is at the heart of business operations. Workday has been implemented, but the usage levels are currently very low. The employer is aware that much more can be done with the system, and they want to capitalize on the tool which they have recently invested in. Main duties and responsibilities for the HRIS Manager role include the following:Maintain and support the efficient use of Workday across the business (globally). Oversee and direct integrations between Workday and other HR software.Lead end to end configuration, testing and deployment of current and new business processes in Workday (& ADP).Assist payroll with administration and maintenance of ADP Workforce now and ADP Workforce ManagerIdentify areas of opportunity to improve existing technology processes, functionality, and workflow, and maximize technological capabilities to reduce manual processes.Works with HR and appropriate internal and external partners to define procedures for HR processes that involve systems (benefits, compensation, performance, onboarding, etc.)Collaborate with IT to integrate HR systems with other business systems.Be a global thought partner with our stakeholders to maintain data integrity; develop tools and audit processes to ensure accurate and timely data.Provides training, demos, and documentation to HR Team and organizational leaders.Ensure HRIS system compliance with federal and state regulations, data security and privacy requirements.To confirm, this is a HYBRID ROLE. Three days per week are required on-site close to Norwood, MA, with Wednesday being the core HR day each week.Apply now using the link provided to advance your career as a valued HRIS Manager!MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.In return for a competitive remuneration package, the successful candidate will possess the following:Bachelor's degree in a related field (i.e., Human Resources, Finance, Accounting, BusinessAdministration).5+ years of relevant HR experience, with a strong focus on WorkdayAbility to work on-site close to Norwood, MA, 3 days / week

Atrius Health, an innovative healthcare leader, delivers an effective system of connected care for more than 690,000 adult and pediatric patients at 30 medical practice locations in eastern Massachusetts. Atrius Health's 645 physicians and primary care providers, along with 420 additional clinicians, work in close collaboration with hospital partners, community specialists and skilled nursing facilities. Our vision is to transform care to improve lives. Atrius Health provides high-quality, patient-centered, coordinated, cost effective care to every patient we serve. By establishing a solid foundation of shared decision making, understanding and trust with each of its patients, Atrius Health enhances their health and enriches their lives. Atrius Health is part of Optum, a health services company focused on building the leading value-based care system in the country. SUMMARYAs a member of the clinical care team, is responsible for supporting efforts to meet Atrius quality goals by facilitating both routine preventative care and ongoing chronic disease management for primary care patients. Works in a matrix function with overall direction from clinical and administrative leadership at the IM Service Line and the Performance Excellence department, and daily supervision from clinical and administrative leadership at the IM practice site. Identifies and articulates opportunities for work flow changes to improve quality of care related to the organizational strategic quality goals. Understands complex characteristics of the quality metrics and translates the metrics into actionable workflows for the clinical practice. Serves as the organizer and driver of population management outreach work at the site, and plays a key support role for onboarding patients to the practice. Navigates data for large populations of patients to identify recommended clinical care opportunities and subsequently organizes and prioritizes action items, including allocating tasks to the appropriate member of the care team and ensuring efforts are coordinated and avoid duplication. Manages a high volume of patient outreach for patient populations with chronic illnesses (e.g., diabetes, hypertension and cardiovascular disease) as well as for primary care patients needing preventative screening tests within the broader patient population. Builds relationships with patient in order to assist the primary care team in developing an effective and accessible plan of care and ultimately tracks adherence to this plan of care. Note: The role of Population Management Care Facilitator involves complex and detail-oriented responsibilities, the ability to understand and articulate clinical terms and processes and the ability to interact with patients and clinicians about preventative health and chronic disease management. EDUCATION/LICENSES/CERTIFICATIONSHigh School diploma or equivalency certificate (e.g. GED, HiSET, TASC Test) from an accredited institution or governmental unit required. Associates Degree or some college preferred. Degree in healthcare field preferred. EXPERIENCESkills and experience typically acquired through three years (one of which is calculated from degree) in a: clinical business support, or clinical research, or ambulatory care setting, or customer service business. Previous training or experience in population health management preferred. SKILLSProficiency in the proven ability to extract data and manipulate spreadsheets, and/or understand and utilize principles of data analysis required. Proficiency in Microsoft Office. Strong interpersonal skills required with the ability to build productive relationships with physicians, other professionals, internal staff and patients. Comfortable in sharing information in a positive and encouraging manner. Proven ability to deal with conflict. Excellent time management and organizational skills required with the ability to manage multiple quality projects/initiatives. Ability to work with a high degree of detail in a busy and demanding environment. Must possess effective communication skills both verbal and written, in the English language. Excellent phone skills, strong customer service and ability to build relationships with patients by phone are required. Ability to work independently as well as within the network for the clinical department and the larger population management coordinator group. EMR experience and/or aptitude to master the EMR based on proficiency in other technology experience required. Knowledge and understanding of medical terminology strongly preferred. Proficiency in Excel strongly preferred. Atrius Health is committed to a policy of non-discrimination and equal employment opportunity. All patients, employees, applicants, and other constituents of Atrius Health will be treated with respect and dignity regardless of race, national origin, gender, age, religion, disability, veteran status, marital/domestic partner status, parental status, sexual orientation and gender identity and/or expression, or other dimensions of diversity. Benefits Include:* Up to 8% company retirement contribution,* Generous Paid Time Off * 10 paid holidays,* Paid professional development,* Generous health and welfare benefit package.Atrius Health is an equal opportunity/affirmative action employer and does not discriminate in recruiting, hiring, training, promoting or any other employment practices on the basis of race, color, religion, sex, marital status, age, sexual orientation, gender identity, national origin, military service or application for military service, veteran or disability status.Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA);Equal Employment Opportunity (EEO); and Employee Polygraph Protection Act (EPPA).VEVRAA Federal ContractorRequest Priority Protected Veteran & Disabled Referrals for all of our locations within the statePDN-9bd5600e-9ada-4dfa-9f99-607b7f92650f

6 Month ContractNorwood, MAPR: $25-34/hourShifts:2nd shift = 2pm-12am, Wednesday-Saturday (15% shift differential)OR2nd shift = 2nd Shift, 2pm - 12am Sun-Wed (15% shift differential)OR3rd shift = 10pm-8am, Wednesday-Saturday (25% shift differential)Job SummarySeeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.Job ResponsibilitiesSample coordination including cross functional collaboration with internal and external labsReceipt, processing, distribution and shipment of the following sample types:In-Process, DS, Formulation and DPEquipment cleaningStabilityRaw MaterialsCoordinating domestic and international sample shipmentsCommunication with external Contract Test Labs (CTLs)Interact with Development teams in a GMP compliant mannerInspect product and raw material retention samplesLIMS (LabVantage) sample logging and result entryAQL visual inspection of drug productStability program supportControlled temperature unit management, maintenance and troubleshootingClean room gowningManaging/stocking of QC lab suppliesWrite/revise SOPs, protocols and reportsComplete and maintain cGMP documentation for work performedParticipate in authoring quality systems records such as deviations, change controls, CAPAs.Support non-conformance investigationsEstablish and maintain a safe laboratory working environmentThis position will support first shift QC Sample Management operations at Moderna, Wednesday through SaturdayAdditional duties as may be assigned from time to timeEducation & Qualifications Education: Bachelor's degree in a relevant scientific disciplineExperience: At least two years in a cGMP laboratory settingDemonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.General laboratory operations (Pipette and analytical balance use.)Strong technical writing skillProficiency with Microsoft Office ProgramsQuick learner with electronic databases (e.g. LIMS, SAP, LMS)Strong written and oral communication skills as well as organizational skillsGeneral knowledge of industry standards and guidelines for quality control laboratory operationDemonstrated ability to work effectively under established guidelines and instructionsAbility to collaborate effectively in a dynamic, cross-functional matrix environment.Be able to follow the relevant Standard Operation Procedures as written.Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.Qualifications and Experience:Bachelor's Degree in life sciencesHigher degree preferred or equivalent experience10+ years' experience in biotech or pharma with 7+ years in Regulatory AffairsExperience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.Responsibilities:Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.Leading working groups tasked with developing regulatory submissions e.g. IND working group.Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overallProviding regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator's Brochure (IBs)Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)Reviewing external communications e.g. Publications, Press Releases, Clinicaltrial.gov postings for regulatory complianceIdentifying and managing subject matter experts engaged to support regulatory activitiesEnsuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.Qualities:Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.Prepared to be hands-on as well thinking strategically.Communicate well with internal and external stakeholders.Be able to effectively articulate to Senior Management regulatory risk and the potential impact.Corbus Culture:Our passion. Our purpose. At Corbus, it starts at our core.We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what's best for patients.About Corbus:Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGF? and an antibody drug conjugate targeting tumors expressing nectin-4. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus,visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.

Job Description:This role reports through the Clinical function which provides scientific expertise necessary to design, implement and interpret data from clinical studies. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies in collaboration with Clinical Operations. This role will be responsible for the scientific aspects global clinical trial delivery including protocol design and writing, analysis of data, management and reporting of trials in accordance with company plans/objectives, ICH-GCP, country requirements and company standard operating procedures. Specifically, this includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, supporting site selection, data review and writing/reviewing the clinical study report, for one or more clinical trials. Other important tasks will be supporting the Chief Medical Officer and Head of Operations planning, publication strategy and other tasks.Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.Key Responsibilities:Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, statistical analysis plans, study plans, CSRs.Evaluate innovative trial designs in collaboration with Head of Operations and Chief Medical OfficerIn collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plans to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.Co-lead the cross-functional clinical trial working groups, collaborating with Clinical Operations and extern functions to drive delivery and facilitate issue resolution.Collaborate with Clinical Operations to plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.Collaborate with other Corbus functions to support effective study specific vendor interactionsMaintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team membersDrive the review, analysis, and interpretation of study results ensuring that accurate conclusions are drawn and working with our CMO to appropriately contextualizeIdentify study and program-wide issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution.Conduct literature reviews as needed for the interpretation of study data and development of next steps.Works closely with the CMO to ensure they are informed of pertinent study information, including but not limited to safety and efficacy data.Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports (DSURs) and periodic updates, and clinical sections of regulatory submissions to support product approvals.Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules, support stratification biomarkers.In conjunction with the CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.Qualifications & Experience:Minimum of a BA/BS in Life Sciences Degree with 7+ years of experience or an advanced clinical/science degree e.g. MA + 5 years of clinical or PharmD/PhD +3 years.Significant experience working in early phase oncology is required to ensure proficiency in knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is requireStrong verbal and written communications skills, including an understanding of medical and scientific terminology and the ability to summarize information effectivelyAn ability to work collaboratively with team members and stakeholders from different functions.Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting toolsAdaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.Corbus Culture:Our passion. Our purpose. At Corbus, it starts at our core.We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what's best for patients.About Corbus:Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGF? and an antibody drug conjugate targeting tumors expressing nectin-4. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus,visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.