Salary in Waltham, MA

Outstanding opportunity for a strong training leader who possesses managed markets experience, knowledge of market access, fulfillment, and contracting processes and challenges, and an understanding of the managed care landscape. The candidate should demonstrate a passion for building and delivering development programs supporting all levels of leaders in the organization. Additionally, the candidate will need to thrive in a fast-paced environment, make good decisions with limited information, gain consensus with multiple stakeholders and manage multiple levels of leadership while leading work and deliverables. This is a highly visible and critical role and will report to the Director, Leadership Development and Commercial Effectiveness.PDN-9b4489a3-06eb-4298-886a-bdd622e978b2

Job Description:The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines.• Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc.• Interface with external Regulatory Operations vendor to support submissions to FDA.• Manage, track, and file all required SAE reports to FDA in accordance with Agency guidelines.• Liaise with CRO in the compilation of documents for ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates.• Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.• Participate in cross-functional sub-teams focused on the execution of regulatory strategy.• Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company.• Acquire and manage regulatory intelligence, liaise with regulatory intelligence external vendors (as needed), and communicate information to key stakeholders.• Assist in the setup, management, and maintenance of the regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).Essential Job Functions:• Excellent people skills, and experience developing strategic, and long-term relationships with key stakeholders.• Strong organizational, problem-solving, and analytical skills, as well as the ability to multi-task.• Demonstrated ability to clearly communicate the status of work, issues that arise, and proposed solutions to challenges to manager, team members, and head of the department.• Attention to detail and the ability to work individually, within a multidisciplinary team, and with external parties.• Strong team player who has a customer service approach and is solution oriented.• Ability to work in a fast-paced environment and meet aggressive timelines.• Strong written and verbal communication skills, including some regulatory writing experience.• Advanced knowledge of the Microsoft suite of tools including Word, Adobe, PowerPoint, Excel is required.• Previous RIMS experience is a plus.Qualifications:• BS or MS with at least 4 years of direct experience in Regulatory Affairs in the pharmaceutical/biotech industry.• Strong knowledge of FDA regulations is required.• An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is preferred.• Experience in managing the preparation of regulatory documents including individual modules of a new IND, Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format.• Experience with small molecule drug development is preferred.• Experience with early development programs is a plus.• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.• Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle.• A three-day per week onsite presence is required for effective team interaction.

Job Description SummaryAbout Us: The Center for International Students & Scholars (CISS) at Bentley University, a private business-focused university located in Waltham, Massachusetts is hiring a paid graduate intern for 15 - 20 hours per week for the 2024-2025 academic year (August/September –May). CISS serves 1000 + international students and scholars and strives to keep the institution, students, scholars and their dependents in compliance with immigration regulations through advising and record keeping. Through this engagement, CISS facilitates campus internationalization and makes it possible for all Bentley students to gain both a global perspective and a broadened worldview.Graduate Intern Duties & Responsibilities:Office Administration/ Document Processing:Manage inquiries to the CISS general email inbox and telephoneIntake and initial review of work authorization application materials (CPT/OPT); I-20 reprint requestsUpdate office documents, including forms, cover sheets, office manual, and information session presentationslidesAssist in initial I-20 process for SEVIS-transfer studentsCreate and review orientation materials for incoming studentsAssist with website development and updatesAssist with updating internal office manualProgramming: Assist with programming initiatives for CISS’ WorldView Program, employment informationsessions, and travel signature events, orientation, and other CISS-sponsored programsAdditional responsibilities: data management and assessment, and other areas depending on availability, experience,and interests.Minimum qualifications:Currently or preparing to enroll in a graduate program in International Higher Education, Higher Education Administration, International Affairs, Student Affairs Intercultural Relations, Counseling, Ethnic Studies or related field.Ability to work 15- 20 hours/week in person with possibility of remote workOccasional ability to help with evening programming (Schedule and start date flexible.)Ability to multitask, meet deadlines, and adapt to changing demands and prioritiesExcellent organizational, analytical, and problem-solving skillsAbility to work both independently and collaborativelyStrong demonstrated interpersonal, intercultural, and customer service skillsU.S. Citizen or Permanent Resident (Required to access SEVIS database integral to role)Minimum commitment: 1 academic year (approximately August/September – May)Preferred skills:Knowledge of F-1 & J-1 non-immigrant visa regulationsDialogue facilitation training/experienceProficiency or fluency in a language other than EnglishExperience living outside of the U.S.Experience working with international student populationBentley University requires references checks and may conduct other pre-employment screening.DIVERSITY STATEMENTBentley University strives to create a campus community that welcomes the exchange of ideas, and fosters a culture that values differences and views them as a strength in our community.Bentley University is an Equal Opportunity Employer, building strength through diversity. The University is committed to building a community of talented students, faculty and staff who reflect the diversity of global business. We strongly encourage applications from persons from underrepresented groups, individuals with disabilities, covered veterans and those with diverse experiences and backgrounds.About Us:Bentley University seeks to attract talented individuals who are committed to our mission of educating creative, ethical and socially responsible students who will become organizational leaders nationally and internationally. All members of our faculty and administrative staff play a critical role in creating an inspiring, compassionate and diverse community that cultivates the lifelong development of our students. Bentley believes that promoting diversity plays an essential role in its educational mission by fostering greater innovation and creativity, attracting the widest pool of qualified applicants to its work force, and enhancing its communication and relationships with the community. Bentley is proud to be an employer of choice, offering competitive salaries, comprehensive benefits (including tuition remission), generous time off, a welcoming community and a beautiful work environment. NOTE TO APPLICANTS: Workday Recruit is not compatible with Internet Explorer. When applying for jobs in Workday Recruit, you will need to use either Chrome or Firefox internet browsers.Bentley University does not accept resumes from agencies that have not signed a formal agreement with us.PI238686587

Job #24-30Position: Occupational Health Nurse RNLocation: Waltham & Billerica, MAStatus: Full-time, preferably from 6 am 2 pm (would consider reduced hours); Temp. for 3 months with potential to be hiredClinic Type: Biotech research & developmentSalary: Competitive salary ($47-$50/hour)Duties:Triage, emergency visits and first aidPerforms health screenings and health assessmentsPerforms Disability and Workers’ Compensations RTW case management functionsWellness programsCollaborate with human resources and safetyTravel medicine and immunizationsRequirements:Currently licensed in MA to practice as a registered nurseExperience in Occupational Health or urgent careComputer skills, solid communication and customer service skills

Location: Waltham, MA (Hybrid)Therapeutic Area: OncologyJob Overview: This position involves leading process development, tech transfer, and manufacturing activities for our clients novel oncology platform collaborating with various internal and external stakeholders, and contributing to the development of promising early and late stage therapeutics.Primary Job Responsibilities:Oversee and lead outsourced process development activities for development and manufacturing of API drug substance and drug product components in alignment with CMC strategy and project timelines.Design, review, and report on development studies of drug substance intermediate and final drug product acting as an independent technical leader.Interact with contract manufacturers and development organizations as a representative driving external development, tech transfer, and clinical manufacturing activities.Primary Job Requirements:M.S. in (Chemistry, Chemical Engineering, etc.) and possess 3+ years of industry experience, or alternatively a BS with 5+ years of industry experienceStrong technical experience in process development and technology transfer of small molecules is required, including hands-on expertise in scale-up process chemistry, analytical characterization methods including HPLC/UPLC. Demonstrated experience working directly with or overseeing CDMOs or experience as Person in Plant is required along with a strong foundation in process development and tech transfer.About Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.PROVEN SCIENTIFIC PLACEMENT™Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

ESSENTIAL DUTIESThe requirements listed below are representative of the essential duties required of the Sr Manufacturing Engineer.• Provide DFM and DFT feedback on new products as part of the development team.• Create product workflows and routings.• Create work instructions for internal and external use.• Implement process and design improvements to improve cost, time, and quality.• Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing and new products.• Work with quality on verification and validation procedures to support the launch of commercial manufacturing.• Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency.• Work with the product development team to design manufacturing tooling and fixtures.• Work with production and quality on creating procedures and processes to manage external contract manufacturers as well as internal production.• Manage new product introduction and transition from product development to production.• Lead effort to transition manufacturing of subassemblies to contract manufacturer.• Act as the point of contact for resolving technical issues at the contract manufacturer and the production floor.Education and/or Experience• BS in Engineering or Science required.• Minimum of 7 years' manufacturing experience; in the medical device/FDA regulated industry. Preferably in the capital equipment and or laser field.• Prior experience working with contract manufacturing and transitioning products from design to contract manufacturing.• Working knowledge of the FDA, ISO, and the medical device industry requirements (e.g., FDA QSR, ISO 13485, ISO 14971)

The Construction Project Manager - Commercial (Boston) will be responsible for:Overseeing and directing personnel on site and maintaining communication with the owners throughout the entire processManaging the financial budget and trajectory of the project from start to finishWorks with Project Manager and Project Safety manager to ensure that all safety expectations are met and thoroughly executedResponsible for managing all labor disputes, staffing, construction materials, construction equipment and contracts/subcontracts administrationDevelop strong relationships with Superintendents, Subcontractors, and Assistant Project ManagersMaintain appropriate documentation through projectMPI 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 Construction Project Manager - Commercial (Boston) should have:Bachelor's Degree, preferably in Engineering, Architecture or Construction Management7-15 years of experience in Construction, experience managing multiple projects at a timeTI and ground-up experienceExperience in self perform (demolition, carpentry, etc.Working knowledge of commercial construction technology and details. Candidate must be extremely proficient reviewing and understanding all construction documents including specifications and drawingsExcellent communication skills with various parties including management, subcontractors, consultants, architects, vendors, and clients

**About us** **National Grid is hiring a Lead Machine Learning Engineer, Data Science. The position can be located in Waltham, MA or Brooklyn, NY.**     Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society and our industry is accelerating and our expertise and track record puts us in an unparalleled position to shape the sustainable future of our industry.   To be successful we must anticipate the needs of our customers, reducing the cost of energy delivery today and pioneering the flexible energy systems of tomorrow. This requires us to deliver on our promises and always look for new opportunities to grow, both ourselves and our business. **Job Purpose** As a Lead Machine Learning Engineer on the National Grid Data Science team, you will develop data pipelines, take data science prototype models to production, fix production bugs, monitor operations and provision the necessary infrastructure in Azure. This is a hybrid role with 1 day per week in the Waltham, MA office or Brooklyn, NY office. US Colleagues must reside within our existing footprint, which includes contiguous states (New Jersey, Pennsylvania, Connecticut, New Hampshire, Maine, Rhode Island, and Vermont). A hybrid worker should also reside within a reasonable, commutable distance to their assigned primary office. **Key Accountabilities** • Lead Machine Learning projects end-to-end and develop platform tooling for the Data Science team. • Work with data scientists to understand their data needs and put together data pipelines to ingest data. • Work with data scientists to take data science model prototypes to production. • Mentor and train junior team members. • Enhance and improve the code deployment and model monitoring frameworks and project operations documentation. • Design, provision and maintain the cloud infrastructure needed to support Data Engineering, Data Science, Machine Learning Engineers, and Machine Learning Operations. • Write high quality code that has high test coverage. • Participate in code reviews to help improve code quality. • Work closely with IT to stay up to date on upcoming changes to National Grid's infrastructure. • Technologies/Tools we use: Python, SQL, Azure (Virtual Machines, Azure Web Apps, Cloud Storage, Azure ML), Anaconda packages, Git, GitHub, GitHub Actions, Terraform, Artifactory, Airflow, Docker, Kubernetes, Linux/Windows VMs. **Qualifications** • At least 7 years of hands-on experience implementing AI/ML solutions and platform tooling for Data Science. • Expert in Python which includes experience in libraries such as Pandas, scikit-learn and proficient in SQL. • Knowledge of best practices in software engineering is necessary. • At least 3 to 5 years of hands-on experience in some combination of the following technologies: Azure (VMs, Web Apps, Managed Databases), GitHub Actions, Terraform, Packer, Airflow, Docker, Kubernetes, Linux/Windows VM administration, Shell scripting (primary Bash but PowerShell as well). • A solid understanding of modern security and networking principles and standards. • A foundational knowledge of Data Science is strongly preferred. • Bachelor’s or higher degree in Computer Science, Data Science, and/or related quantitative degree is preferred from an accredited institution. **More Information** Salary Waltham: $143k - $168k a year Brooklyn: $153k - $180k a year This position has a career path which provides for advancement opportunities within and across bands as you develop and evolve in the position; gaining experience, expertise and acquiring and applying technical skills. Candidates will be assessed and provided offers against the minimum qualifications of this role and their individual experience. **National Grid is an equal opportunity employer that values a broad diversity of talent, knowledge, experience and expertise.  We foster a culture of inclusion that drives employee engagement to deliver superior performance to the communities we serve.  National Grid is proud to be an affirmative action employer. We encourage minorities, women, individuals with disabilities and protected veterans to join the National Grid team.**

**About us** Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society and our industry is accelerating and our expertise and track record puts us in an unparalleled position to shape the sustainable future of our industry. To be successful we must anticipate the needs of our customers, reducing the cost of energy delivery today and pioneering the flexible energy systems of tomorrow. This requires us to deliver on our promises and always look for new opportunities to grow, both ourselves and our business. **About the role** The ERM Lead, working under Director Cari Schafer, is a trusted advisor, driving effective risk management practices across the organization. They lead initiatives to elevate the ERM program, collaborating with stakeholders to develop and enhance risk management strategies. With expertise in risk analysis and reporting, they provide timely insights to business leaders on risk matters and input to Group Reporting. The ERM Lead fosters a risk-aware culture, develops organization-wide policies, and maintains external relationships to provide thought leadership and innovations. In summary, the ERM Lead plays a critical role in promoting impactful risk management and governance practices. **What you'll do** + Serve as a trusted business advisor, providing expert guidance in risk management to the first and second lines of defense. Proactively gather and analyze risk reporting materials, delivering concise and impactful reports to business unit leaders and executive management. + Lead initiatives to elevate the ERM program, collaborating with stakeholders throughout the organization. Develop, implement, and enhance risk management strategies to drive continuous improvement. Provide expert insights and analysis on specific risk areas during their risk reviews, ensuring effective risk mitigation and informed decision-making. + Advise on, and contribute to, ongoing enterprise risk register development for risk identification and measurement, carrying out reviews with business risk owners and their delegates regularly. + Assess and provide review on internal controls and risk management effectiveness across the Group, specifically providing insight around the integration and embedment of the ERM framework within the business. + Oversee the design and implementation of risk reporting and monitoring systems to provide timely and accurate risk information to business unit leaders and executive management. + Maintain and improve risk management framework documentation, training materials, and provide training to key stakeholders on the ERM framework. + Drive the development of robust organization-wide policies, procedures, and guidelines, ensuring effective risk management and governance practices. + Monitor and assess emerging risks and trends in the industry and make recommendations for proactive risk management strategies. + Foster a risk-aware culture by promoting good practice risk management practices throughout the organization. + Coordinate and collaborate across the 2nd Line and with internal and external auditors. + Stay updated on evolving risk management practices and technologies to provide thought leadership. **What you'll need** + Over 5 years' experience in professional risk management field (including time in assurance and audit professions) + Experience working on ERM projects and teams to deliver strategies, policies and framework improvements + Risk Management or equivalent professional certification (examples include Enterprise Risk Management Certified Professional (ERMCP), Certified Risk Manager (CRM), Certified Risk Management professional (CRMP), Chartered Accountant (CA), Certified Public Accountant (CPA), Associate in Risk Management (ARM), International Certificate or Diploma in Risk Management). **What you'll get** \#LI-NK1 #LI-HYBRID Annual Salary NYC Area: $133,000-$156,000 Waltham, MA Area: $124,000-$146,000 Syracuse, NY Area: $111,000-$130,000 Salary commensurate with experience and location: This position has a career path which provides for advancement opportunities within and across bands as you develop and evolve in the position; gaining experience, expertise and acquiring and applying technical skills. Candidates will be assessed and provided offers against the minimum qualifications of this role and their individual experience. **National Grid is an equal opportunity employer that values a broad diversity of talent, knowledge, experience and expertise.  We foster a culture of inclusion that drives employee engagement to deliver superior performance to the communities we serve.  National Grid is proud to be an affirmative action employer. We encourage minorities, women, individuals with disabilities and protected veterans to join the National Grid team.**

The Project Manager is responsible for:Leading custom residential projects from start through completionManaging deadlines and making sure timelines are metCoordinating with necessary project team membersPositive client feedback/satisfactionBuilding relationships 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 Project Manager will have:Project management experience with a reputable residential firm (4+ years)Knowledge of construction methods and materials, costing, & schedulingAbility to organize, think ahead, plan, and manage multiple prioritiesStrong relationship building & managing skillsExcellent interpersonal and communication skillsComputer savy-ness