41 manager benefits jobs found in Waltham, MA

Alkermes, Inc. Responsibilities Responsible for all quality systems in scope from the Global Process Function/Operational process standpoint. Report to the Director of Quality Systems and Compliance. Responsible for initial implementation and validation support, periodic review and operational support to maintain systems in a validated state. Facilitate development, maintenance, and reporting of Quality System metrics to senior leadership on a periodic basis. Facilitate development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management in-line with Alkermes Quality philosophy, regulations, and industry best practices. Evaluate and lead initiatives on harmonization of Quality Systems management. Facilitate and lead continuous improvement of approach to quality systems and processes by identifying, proposing and implementing systemic changes. Coordinate with other impacted Quality groups and Site Process Owners to gather...

CSL CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional...

Alkermes, Inc. Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases IIV of development. Responsibilities Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation,...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! A fast-growing and acquisitive global public company is looking for a strong, experienced, and detail-oriented Senior Director of Finance reporting directly to the Vice President of FP&A. This represents an opportunity to work in a key finance leadership role with significant levels of executive visibility. This role must pay great attention to detail, deliver results, and operate cross-functionally in a rapidly changing environment. This role is a critical business...

Alkermes, Inc. The Alkermes Commercial Learning and Leadership Development (CL&LD) team is looking for someone who will lead the development of field training programs supporting Alkermes' growing portfolio of mental health treatments. The successful candidate will be responsible for the full portfolio of Alkermes promoted products and Commercial field teams. This position is ideal for someone who enjoys working in an entrepreneurial environment creating impactful, world class training programs that support sales force effectiveness. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. Responsibilities Key Duties: Curriculum / Workshop Development Deliver and evaluate training programs, curricula, and training materials for field representatives, account managers and field management Facilitation Organize and...

CSL Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They will lead issues and crisis management related to pipeline. In addition, they will strengthen the company's reputation within the Waltham biotech ecosystem and US to enhance and protect CSL's reputation and policy position. Reporting Relationships: Reports to: Head of Corporate and External Affairs, R&D Direct reports to position: 1 Main Responsibilities and Accountabilities: Serve as primary business partner and strategic advisor to SVP, Portfolio Development, SVP, GRAS and VP, Portfolio and Operations Excellence to shape...

Alkermes, Inc. This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. Travel requirement of 40% - 60% Responsibilities This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites...

CSL Position Title: Senior Manager, Corporate & External Affairs, R&D Portfolio Position Purpose: The Senior Manager, Corporate and External Affairs, R&D Portfolio will execute the corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for executing communications for key pipeline milestones and clinical trials. They will manage issues and crisis management related to pipeline. In addition, they will develop and implement initiatives to strengthen the company's reputation within the Waltham biotech ecosystem and broader US environment to enhance and protect CSL's reputation and policy position. Reporting Relationships: Reports to: Associate Director, Corporate & External Affairs, R&D Portfolio Main Responsibilities and Accountabilities: Support the Associate Director in serving as a business partner and advisor to senior leaders, assisting with the shaping and communication of...

Alkermes, Inc. The Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs. Responsibilities Review clinical trial protocols and understand impact on supply Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans Create, review, and update...

Alkermes, Inc. The Alkermes Patient Access Services (PAS) team provides support for patients wishing to access Alkermes products. Support includes reimbursement and access education, appointment reminder support, coordination to financial assistance and assistance locating follow on providers for site of care transitions. The Alkermes PAS team works with patients, healthcare providers and insurance companies. The Manager-HCP Experience, PAS position reports to the Senior Director - HCP Experience, PAS and will play a key role in the delivery of our case management services and patient support programs. The role will oversee the PAP program for all 3 brands in addition to a team of case managers. This position is ideal for someone who enjoys working with multiple cross-functional teams to deliver solutions that improve patient access to medications and treatment. This person will be responsible for implementing PAP program enhancements, ensuring program performance, responding...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! IT Manager, SOX & ITGC Compliance We are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls over financial reporting and key digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting, and external auditors to strengthen Repligen's control environment. Responsibilities...

Alkermes, Inc. JOB DESCRIPTION Position Summary As a Senior Manager, Data Science within the INDIGO | AI Innovation Lab, you will play a hands-on role in developing analytical, traditional ML, and AI products and in supporting delivery of prioritized AI use cases on our roadmap. You will collaborate with business stakeholders on specific deliverables, maintain ownership of your work and ensure timely delivery of quality products. You will bring solid technical expertise and a strong sense of work ownership to a deeply collaborative setup, where AI innovation with strong business integration is paramount. The ideal candidate will have experience with data science and AI applications in the pharmaceutical or health-related industry. This role is based in our Waltham location and follows a hybrid office schedule. Responsibilities RESPONSIBILITIES Technical Development and Execution Design, develop, and deploy data science solutions including GenAI chatbot...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary: Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk assessment and decision...

Revvity Overview Revvity is seeking a skilled and motivated Senior Tax Manager to join our Global Tax team in Waltham, MA. In this role, you will identify and implement strategic tax planning initiatives, and operationalize global transfer pricing and compliance, including engaging in U.S. international tax compliance and reporting. This is a high-impact position where your expertise will drive value through innovative tax strategies and operational excellence. This is a hybrid opportunity with a Tuesday - Thursday on-site work schedule based at our headquarters in Waltham, MA. Key Responsibilities: Support cross-functional tax planning initiatives, including transaction structuring, supply chain optimization, and commercial enablement. Manage global transfer pricing documentation and ensure operational compliance across multiple jurisdictions. Participate in the preparation of U.S. international tax filings and tax provision - e.g., computations for GILTI, BEAT,...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional...

Alkermes, Inc. Responsibilities Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS...

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Alkermes, Inc. KEY AREAS OF JOB ACCOUNTABILITY: Provides process and technical leadership and assumes accountability for Quality System applications as assigned and will be ultimately responsible for ensuring that the quality system is compliant, and its operations are fit for intended use in accordance with applicable global procedures. Spearhead the improvement and management of DMS/QMS applications, as assigned, including harmonization of processes across sites. Responsible for defining the directional course of quality systems implementation and upgrade projects, ensuring comprehensive consultation and communication with impacted teams, individuals, and stakeholders. Responsible for requirements - authoring and on-going maintenance by leading and facilitating meeting/workshops with Site Process Owners and Key Users (Business SMEs) Lead development of and approve validation deliverables as a Global Process Owner as assigned- initial implementation and...

Alkermes, Inc. Job Title Senior System Analyst III - Clinical Manufacturing Suite Location Waltham, MA (Hybrid Office Schedule) Position Summary The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep...