Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Vice President of Program Management, the candidate will be responsible and accountable for the coordination and leadership of activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program management support to provide end-to-end oversight of the program strategy and management for initiating, planning, executing, controlling, reporting, and terminating the Integrated Development Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program management leadership, strategic thinking, and business acumen for the development programs for products or devices in a global, matrix organization, from Research to life cycle management. Additionally, the Sr. Director of Program Management will work with the Program Management team and global organization to design new processes and supporting business structures and recommend new and global solutions that drive process standardization and simplification across the company. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Contribute to the success of the Project Management Organization (PMO) in achieving its goals & objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading organizational and program management processes. Drive implementation of key program documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes. Challenge the organization to be innovative, make it safe to try new approaches, and take prudent risks. Coach the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions. Be accountable for the alignment between the Global Asset Team (GAT), Functions and Portfolio plans such that the forecasted benefits of the program are achieved. Find opportunities for leveraging investments and creating value, including external innovation or partnerships. Establish Global Asset Team (GAT) strategies with goals & objectives in alignment with functional, geographic, and organizational objectives. Ensure the development of program plans are in alignment with corporate strategy, and that the plans are tracked and managed. Work with respective functional leaders to drive the creativity of innovative product target profiles and product development plans that optimize value, time, resources and risk while ensuring that program strategy is aligned with business objectives. As the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation through proactive communication to the teams and Senior Leaders. Drive teams to meet or exceed goals by providing superior global cross-functional leadership and management in a matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management, contingency planning and decision-making. Lead and direct integrated teams to plan, execute, control, report and close-out all program related work across all functions (e.g., integrated program budget, risk, timeline, resource, and stakeholder management). Other projects and assignments, as required. Qualifications Bachelor degree in a scientific, medical or business discipline. An additional/post-graduate qualification will be a distinct advantage (Ph.D., MBA etc.). 10-15 years of Project/Program Management experience with proven management and/or leadership experience in an R&D, manufacturing/operations or commercial context in a biotech/bio-pharmaceutical environment required. Project Management Professional (PMP) certification a plus but not required. Strong interpersonal skills with the ability to influence without authority, motivate with enthusiasm and develop productive working relationships with key stakeholders. Entrepreneurial, self-starter with a proven track record of success in fast-paced and demanding environment and strong desire to "make things happen", including a results-oriented work ethic and a positive, can-do attitude. Must be an experienced pharmaceutical/biotechnology program/project manager with experience in leading drugs through all phases of development and into commercialization. Must be a team player with the highest of personal values and ethical standards. Must have excellent leadership and interpersonal skills; should be an effective team leader who can manage and lead in a matrix environment. Strategic thinker with excellent problem-solving skills and an ability to influence all levels of the company. An ability to take hands-on, "roll up your sleeves" approach toward achieving business results. Ability to quickly gain credibility and confidence with all levels within the company. Well-developed computer skills (e.g., MS Project, Excel, PowerPoint, SharePoint). #LI-KM #LI-Hybrid Travel Requirements Willing to travel within the US and overseas. Travel expected to be ~ 5-10%. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Sr Director Quality Assurance Operations

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers. This is a supervisory position with 3-6 individual direct reports. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes. Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA. Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply. Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operations Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP). Responsible for QA representation in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects. Manage the performance and development of 3-6 direct reports. Support supplier and internal audits as necessary. Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc. Act as company's representative during regulatory agencies and customer inspections. Supports the investigation of product and related CAPAs. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department. Support Statistical Trending of Manufacturing and Analytical Data. Additional duties as assigned Qualifications BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. Commercial drug manufacturing site QA head experience preferred Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness. Ability to solve complex problems and take proactive action Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual. Maintain professionalism, self-motivation, and enthusiasm. Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing. Must perform statistical analysis and capable of analyzing data to solve problems Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines Solid knowledge of all QC laboratory equipment and manufacturing equipment Direct experience with investigations and root cause analysis in pharmaceutical or medical device products. Experience with internal and external audits. Experience reviewing manufacturing and QC validation documents. Preferred ASQ CQE and CQA Certifications. Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971. Demonstrate ability to manage projects and variable workloads. Excellent communication and coaching skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Travel Requirements Up to 30% travel, both domestic and/or international. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Senior Manager Regulatory Affairs

Gan & Lee Pharmaceuticals, Bridgewater

SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. Education and Credentials• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.• RAC certification or other equivalent is preferred.Experience• Minimum Bachelor's degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 3 years of regulatory CMC experience with US product development. • Deep knowledge of US and EU regulations for biosimilars is preferred.• Deep knowledge of regulations for drugs and biologics.• Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.• Experience in various regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development plans, clinical design and other clinical aspects (including document package writing, meetings and discussions with the agency, etc.) is preferred.• Led at least one drug IND application in US and get it approved. Experience in endocrine drugs such as insulin and GLP-1 is preferred.• Experience in working in multi-culture/multi-countries environment is preferred.Skills• Demonstrated ability to manage multiple and diverse projects concurrently.• Demonstrated ability to develop positive relationships and collaborations.• Strong analytical skills; a strategic thinker, planner, and implementer.• Ability to operate independently with minimal supervision. • Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.ResponsibilitiesActively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;Author Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.Drive the preparation and review of regulatory submissions, such as INDs, BLAs, MAAs, meeting packages to ICH member Health Agencies, and supplemental filings ensuring regulatory documents are written per guidelines and timelines.Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.

Rebate Analyst I

Amneal Pharmaceuticals LLC (J0P), Bridgewater

Description: This Rebate Analyst is responsible for validating, reviewing claims and the reconciliation of discrepancies for wholesalers, distributors, retailers, medical, and/or biosimilar claims, etc., while adhering to strict timelines and contractual obligations. These claims often are comprised of difficult strategies and are codependent on sales from multiple areas, so this person must have excellent analytical skills and be extremely proficient in Excel. The rebate analyst must have the ability to work independently and be able to multi-task. They must be organized, detail oriented and able to work under pressure. They must possess good communication proficiency and be able to carry on clear and decisive communication between customers and colleagues in various departments and management. Essential Functions: Validate, review, adjudicate, and process all assigned customer claims fees for accuracy and eligibility based on customer specific agreements and on corporate policy. Develop a good understanding of Amneal policies as well as customer specific agreements to correctly reimburse customers for their rebate claims. Process payments through Flex adjudication system and/or JDE and prepare all claim documents for review and approval by management. Update and maintain fee documentation on various rebate trackers per departmental policies. As required by contract terms, manage customer relationship through communication between both parties by sending required reports or other requested backup. When needed, identify issues, and prepare reconciliation of all discrepancies. Identify root cause of issues with discrepancies and recommend corrective action to eliminate future occurrences and reduce outstanding rebate deduction balance. Communicate payment and dispute information directly to customers and provide follow-up data when requested. Discuss explanation of policy and interpretation of customer contract language with customer to support payments and disputes. When necessary, work with customers and management, to obtain payback and resolution to disputes, contributing to overall department saving targets. Work collaboratively with other departments such as Accounts Receivable and Account Managers to monitor and manage customer accounts and provide input on customer-related claims. Perform reconciliation analysis of assigned customer debits compared to Amneal-issued credits. Partner with A/R to resolve variances as well as day-to-day troubleshooting. Work with A/R on collection of outstanding aged paybacks. Contribute to the GTN monthly close reports by ensuring JDE is updated with comprehensive notes. Performs ad-hoc analytics to investigate claim discrepancies or data needs for management, as well as internal or external customers. Take the initiative to analyze data to ensure accurate review of all claims. Meet all compliance related requirements, including any audit requests, SOX requirements, and adherence to all policies and procedures Provide data and analysis to internal and external audit teams, as well as documentation proving adherence to the department’s SOX controls. Additional Responsibilities: Other duties as assigned, including but not limited to, reduction of aging fees and maintenance of Rebate Tracker or maintaining other metric related tools. Performs other functions as required or assigned. Complies with all company policies and standards. Education: Bachelors Degree (BA/BS) Accounting, Finance, or other financial area of study - Required Experience: 1 year or more in Minimum of 0-2 years financial related experience. less than one year in Experience preferred in the Pharmaceutical Industry. Skills: Working knowledge of Microsoft Office Suite (Excel, Word, Outlook, and Powerpoint) - Advanced

Project Manager - Hospitality, Restaurant, Retail

Michael Page, Bridgewater

Project Leadership: Lead the overall planning, execution, and successful delivery of ground-up hospitality and multifamily projects on the South Shore. Manage project teams, contractors, and stakeholders to ensure efficient progress and adherence to quality, budget, and timeline goals.Project Planning: Develop comprehensive project plans, including budgets, schedules, and resource allocation. Coordinate with architects, engineers, and other professionals to ensure accurate and detailed project documentation.Financial Management: Monitor project budgets, expenditures, and cost control measures. Collaborate with the finance team to provide accurate financial forecasts and analysis throughout the project lifecycle.Contract Negotiation: Negotiate contracts and agreements with subcontractors, suppliers, and vendors. Ensure compliance with company policies, regulations, and legal requirements.Stakeholder Management: Build and maintain strong relationships with clients, architects, engineers, and other project stakeholders. Regularly communicate project updates, address concerns, and ensure client satisfaction.Quality Control: Implement and oversee quality control measures to ensure adherence to project specifications and industry standards. Conduct regular site inspections to monitor progress, identify issues, and propose effective solutions.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.Bachelor's degree in Construction Management, Civil Engineering, or related field (Master's degree preferred)Minimum of 5 years of experience as a Project Manager, preferably in ground-up hospitality and multifamily projectsProven track record of successfully delivering projects on time, within budget, and meeting quality standardsStrong knowledge of construction management principles, processes, and best practicesExcellent leadership skills with the ability to motivate and guide project teamsProficiency in project management software and toolsExceptional communication and interpersonal skillsAbility to travel to project sites as required

Quality Control Associate

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview The Quality Control Associate will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage GMP development testing. Responsible for ensuring timely processing of data produced by internal and contract laboratories and testing performed by manufacturers of all commercial and late stage development products, including starting materials, in-process, release, and stability testing throughout the product lifecycle. • This position will not have direct reports • This role oversees data management of vendors and/or contractors Responsibilities Assists in the oversight of contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve if neededMeasure performance against established Key Performance Indicators (KPIs), thereby consistently ensuring timely and accurate testing, reporting, and releaseThis role will assemble, review and trend release, IPC, and stability data, generating reports as necessaryNotifies laboratory management when unusual results, trends, or data deviations occur. Assists in composing investigations as it pertains to testing and results Assists with documentation formatting. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates. Communicating potential issues/obstacles and escalating as necessaryAssist in the development of new processes and process improvementsAssist in determining priority of urgent items and appropriate action plan to effectuate priorityCross-functional liaison working closely with internal stakeholdersProvide statistical programming and data management supportContributor of statistical analyses and interpret results of these analyses Qualifications The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, or equivalent science programMinimum of 2 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testingKnowledge of QC processes and procedures and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulationsKnowledge of Statistical programming preferredExcellent presentation skills both verbal and writtenHighly proficient in Microsoft Office (Word, PowerPoint, Outlook, Teams)Ability to define problems, collect data, establish facts, and draw valid conclusions requiredAbility to establish and maintain cooperative working relationships with internal and external partners requiredAbility to take initiative and work independently while effectively managing timelines as required Understand good documentation practices.Utilize electronic systems to track and manage informationHighly organized and self-motivated with a strong attention to detail.Experience with Veeva preferred. Travel Requirements 10% Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $60,000.00 to $78,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.#LI-JK1

Manager Regulatory Operations

Insmed Incorporated, Bridgewater

Manager Supply Chain Logistics

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview The Manager of Supply Chain and Logistics plays a crucial role in supporting both the commercial and clinical supply chains at Insmed. The primary focus is on managing import/export requirements and collaborating with third-party logistics companies. This position involves serving as the main point of contact for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets. The role also requires contributing to build and maintain Insmed's master data management practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role oversees vendors and/or contractors Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Strategic Planning Collaborate with senior leadership and cross-functional teams to develop and implement strategic plans for the supply chain and logistics operations. Identify and assess potential risks in the supply chain and propose mitigation strategies. Vendor Management Establish and maintain strong relationships with third-party logistics companies and other relevant vendors. Oversee day-to-day interactions with vendors, ensuring adherence to contractual agreements and performance expectations. Monitor and analyze vendor management key performance indicators (KPIs). Shipment Management Oversee the day-to-day management of shipments, ensuring timely and accurate deliveries. Implement tracking systems to monitor the progress of shipments and address any issues that may arise. Implement quality control measures to ensure the integrity and safety of shipped products. Investigate and address any deviations from quality standards in collaboration with relevant teams. Budget Tracking Develop and manage budgets for supply chain and logistics operations. Monitor expenditures, identify cost-saving opportunities, and ensure financial objectives are met. Import/Export Compliance Ensure compliance with all import/export regulations and requirements. Stay informed about changes in international trade regulations and implement necessary adjustments to the supply chain processes. DSCSA Compliance Demonstrate expertise in the Drug Supply Chain Security Act (DSCSA) requirements. Implement and oversee compliance measures to ensure the traceability and security of pharmaceutical products throughout the supply chain. Master Data Management Utilize experience with master data management to ensure accurate and consistent data across the supply chain systems. Implement and maintain data governance practices to enhance data quality and reliability. Qualifications Qualifications Bachelor's degree in Supply Chain Management, Logistics, Business, or a related field. Master's degree is a plus. Proven experience (5 years) in supply chain and logistics management, preferably in the biotech or pharmaceutical industry. Skills Strong understanding of import/export regulations and compliance. Experience with master data management practices. Familiarity with DSCSA regulations and compliance. Demonstrated experience in managing third-party logistics companies and vendor relationships. Excellent project management and organizational skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills for cross-functional collaboration. Proficiency in relevant software and technology, including supply chain management systems. #L #LI-KM #LI-Hybrid Travel Requirements Able to travel up to 10% (Domestic and/or International) Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $108,000.00 to $150,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.#LI-JK1

Accounting Administrator

Greenman-Pedersen Inc, Bridgewater

Job Preview GPI offers excellent benefits, including a 401(k) plan, ESOP, medical/dental/vision plans, paid time off, and more. GPI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, or protected veteran status. M/F/D/VNotice To Third-Party AgenciesGPI does not accept unsolicited resumes from recruiters and/or agencies. Any staffing/employment agency, person, or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of GPI and has the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person or entity.GPI will not pay a placement fee unless the agency or recruiter has a signed contract with GPI's Corporate Human Resources department in advance of submitting a candidate for consideration. Staffing/employment agencies must submit applicants to the designated GPI recruiter to be eligible for a placement fee. Verbal and written approvals will not be considered a valid contract for service.Work AuthorizationIn compliance with the Immigration Reform and Control Act of 1986, we will hire only U.S. citizens and aliens lawfully authorized to work in the United States (if the position is or will be one that is subject to U.S. law). Verification of employment eligibility will be required at the time of hire. Visa sponsorship is typically not available for entry-level positions. GPI participates in E-Verify. Know your Right to Work.Job Description Are you an accounting professional looking for a collaborative team that will both challenge and support you? Do you thrive in being responsible for developing and delivering quality documents? Are you interested in joining a company that puts employee satisfaction and professional growth at the center of its culture? If so, GPI is the place for you!GPI seeks a motivated individual to join our New Jersey accounting team in our Bridgewater, NJ Office. As an Accounting Administrator, you will work with our accounting team to develop and process company invoices and reports. In this role, you'll balance multiple projects that could include a wide variety of our clients, including state agencies, municipalities, and private entities.The team collaborates, ensuring everyone is challenged but has the support needed to meet objectives successfully. This position provides various accounting, project management and support tasks. The ideal candidate will be looking to develop with our team, aligning with our corporate culture of organic growth.GPI is a multi-discipline engineering firm providing planning, design, and construction services for transportation infrastructure and building system projects throughout the United States for over 50 years. Ranked in the Top 100 Firms by Engineering News Record, GPI is a forward-thinking, innovative firm with a culture committed to excellence and fosters staff empowerment. For more information, visit: www.gpinet.comResponsibilities: Set up projects based on client contracts Prepare monthly invoicing for Cost Plus, Lump Sum, and Time & Materials contracts Work closely with Project Managers on billing, project budgets, project progress, and compile associated reports from Deltek VantagePoint Create, update, and edit advanced Excel spreadsheets as needed Use organization and time management to address pressing project matters when time is limited, and to manage multiple tasks, sometimes for multiple projects or project managers at once Problem solving/analysis; ability to research and analyze various types of information Assist with other accounting and administrative duties as needed Work independently as well as in a team-oriented environmentQualifications: Associate degree in accounting or a related field, or an equivalent combination of education and experience 1-3 years of invoicing experience Experience in the AEC or similar industry Intermediate to advanced knowledge of Excel Working knowledge of Deltek Vision or VantagePoint is a plus Strong time management skills and attention to detailsRequirements MINIMUM REQUIREMENTS:Read, write, and understand plans and directions given in the English languageBasic computer skills with the ability to create and edit Microsoft Word and Excel documents, create Outlook emails and utilize SharePoint and Microsoft Teams to communicate with other team members

Content Strategist - III

The Judge Group Inc., Bridgewater

Location: Bridgewater, NJDescription: Our client is currently seeking a Content Strategist - III This job will have the following responsibilities: 1. Working knowledge of Oracle ATG BCC Catalog and Databases; Import, export, bulk update, Create variable, and CRUD operations (Create Update Update Delete) 2. Experience working closely with software development teams and integrating with their development processes for pushing new code and making changes to existing code.. 3. Create test data for verification of latest code releases in the process of software development. 4. Experience working to make changes to live Production environments using best practices. 5. Ability to prioritize tasks and to be available to jump on calls to work on higher priority issues calls when required. 6. Working outside working hours (weekends, night, holidays) to deliver Promotions to production. 7. Working experience with JIRA (Atlassian), SDLC (Agile), working knowledge of multiple CMS (Control Management System) web development frameworks, HTML, CSS. 8. AEM (Adobe Experience Manager) working experience. how to find and make correct changes in existing JSON files, ability to create new nodes in AEM files. 9. Knowledge of code versioning for development using git with GitLab, GitHub, Bitbucket. (branching, merging, etc). 10. Consistently update documentation to promote knowledge transfer and competency; Various documentation topics such as Promotions (including AEM changes), Plans, SFO, SPO and Devices in BCC and AEM. 11. High speed fiber internet connection allows work without interruption. 12. Skilled in Google Workspaces / G Suite: Google Sheets, Docs, Slides. 13. Adapted to Remote work with any video conferencing and productivity software: Zoom, Slack, Blue Jeans, Webex and other chatting and screen sharing softwares experience Qualifications & Requirements: Hybrid, 2 days/week in the office Contact: [email protected] job and many more are available through The Judge Group. Find us on the web at www.judge.com