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Project Controls Manager Salary in Bridgewater, NJ

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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.
Sr Director Program Management
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 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.
Java Developer - IV
The Judge Group Inc., Bridgewater
Location: Bridgewater, NJDescription: Our client is currently seeking a Java Developer - IV Title: Java Developer - Iv Location: Basking Ridge, NJ (Hybrid) Duration: Long Term ContractJOB DESCRIPTION Hybrid: 3 days in office and 2 days remote/week B.S. or equivalent work experience Description: Responsible for the design and development of medium to highly complex systems. Skills include system design and analysis as well as business skills. Works with data and project managers to understand systems and consults with customers to understand needs. Developments and implements new systems, corrects software errors in existing systems, and works to improve performance through hardware upgrades. Manages computer systems in a business environment and responsible for resolving technical issues. Knowledgeable in programming, data structures, computer systems, and software engineering. Bachelor's degree in computer science, software engineering, or other related field. Ability to manage multiple assignments. Superior written and oral communication skills. This position is for a Front-end application development with excellent hands-on experience. Required Skills The candidate to fill this position should have hands-on experience using the following technologies: ? Extensive development experience with Java/J2EE, Core Java, Camel framework, Multi-Threading ? Hands on experience with Node.js, Angular js, Angular 5, HTML,CSS, Bootstrap ,React, JavaScript ? Hands on experience with Java/J2EE, Core Java ,Spring Boot. ? Experience in developing responsive web design, and cross-browsers compatibility. ? Experience in implementing Ngrx-Store ,Grunt, angular-cli and Redux Library. ? Experience with static analysis tools such as Sonar Cube, Fortify. HTML/CSS/Java, JavaScript with responsive design, Bootstrap, Angular. ? Experience with Node.JS, Express and REST API. ? Experience in responsive web design, and cross-browsers compatibility. ? Familiarity working with projects tracking systems, such as Jira. ? Hands-on experience with source control system such as Accurev, Maven, Git Candidate should be able to apply commonly used integration patterns in solution design and implementations and should be self-sufficient to develop a solution given the business requirements and high-level design. End-to-End Systems Responsibility: Analysis and Design ? Analyze architecture, relationship between systems, and systems flow of end-to-end designs ? Identify potential performance constraints with inter-system designs ? Evaluate solution?s alignment with the end user experience Software/ Application Development & Architecture ? Develop systems and applications using complex algorithms to deliver business functions or architectural components ? Apply appropriate integration patterns based on technical requirements and high-level design Testing ? Unit and integration test code using happy and exception paths ? Test business processes/products across applications with an end-to-end process flow System & Network Security ? Reduce security threats with dependable & reliable security tools & software applications ? Have and apply knowledge of secure programming techniques to reduce vulnerability to business application Technical Communication ? Communicate technical details to various audience types ? Select appropriate communication medium ? Experience with all phases of the Software Development Lifecycle, including system analysis, design, coding, testing, debugging and documentation ? Teamwork & collaboration skills to work across organizations and lead cross-functional teams ? Problem solving skills to develop quick yet sound solutions to resolve complex issues ? Designing, developing, implementing, testing the applications. ? Relevant experience programming in HTML/CSS/Java, JavaScript with responsive design, Bootstrap, Angular. Experience with Node.JS, Express and REST API. Experience in responsive web design, and cross-browsers compatibility. ? Hands-on experience with static analysis tools such as Sonar Cube, Fortify Contact: [email protected] job and many more are available through The Judge Group. Find us on the web at www.judge.com
Manager Regulatory 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 The Manager, Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related documents in the Company's electronic document management system (EDMS). Responsibilities RESPONSIBILITIES: Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS Contribute to submission planning to identify pending submissions and define priorities. Anticipate upcoming tasks based on the submission timelines. Perform quality control checks and coordinate comment resolution with publishing team. Support authors to complete regulatory documents such that all components are provided and presented in the correct format. Manage document review and approval as needed. Assists with other projects to support the regulatory department as assigned. Provide support in software validation and migration activities relating to new or existing systems in Regulatory Affairs Required Skills 5 years of Regulatory Operations experience Extensive knowledge and experience with Microsoft Office, Adobe Acrobat, Veeva RIM, DocuBridge eCTD Publishing software, DXC Toolbox, WebTrader, Extedo eSubmanager Effective/productive working with minimal supervision Detail oriented Strong written and verbal communication skills Ability to multitask and prioritize when working on multiple projects and deliver on tight timelines within a fast-paced team environment. Flexible in managing shifting priorities. 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 $116,000.00 to $161,333.00 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.
Plant Controller
Anonymous, Bridgewater
This is confidential - once we review your profile we will share the company information.As a Plant Controller, you are a key member of the Plant leadership team. Reporting to the Divisional Controller and the Plant Manager, you will be dedicated to ensuring accuracy, compliance, and efficiency, in all financial reporting. You will also support operational efficiency projects. Specifically, you will:all financial functions related to month/quarter/yearend closings includingentries, conversion costing, income statements, variance analysisanalytical expertise on mission critical data to enhance decision makingforecasting, budgeting, capital investmentsprofitability by identifying opportunities for efficiency improvements and costand improve internal control processes.RequirementsWe are seeking a proactive, polished financial professional with the following skills andexperiences:Degree in Business/Finance/Commerce preferred, commensurate experience acceptable5 years of experience in a manufacturing environment that has included use ofsoftware systemanalytical and statistical data management skillsproject/process management ability