6 senior regulatory support consultant jobs found in Waltham

Alkermes, Inc. The Senior Director, Emerging Technology and Engineering is a critical leadership role responsible for defining the company's technology future across Enterprise Architecture, Data, Advanced Analytics, and core Engineering practices. This role manages an integrated function to ensure our IT roadmap, digital strategy, core technologies, and AI/Analytics capabilities are designed to drive competitive advantage, accelerate business insights, enhance decision-making, and are implemented with high-quality engineering standards. The Senior Director will serve as a primary interface for the Emerging Technology and Engineering Team within the Global IT organization while championing the adoption and maturity of advanced data and analytical capabilities across the enterprise. This role will work a hybrid weekly office schedule in our Waltham location. Responsibilities Strategic Leadership Build and mature IT capabilities to support current and emerging...

Alkermes, Inc. The Executive Director, IT R&D will oversee an IT organization that drives the standard and compliant delivery of IT R&D support and services. Key objectives for this role will be to establish technology delivery standards for the R&D function based on business need. The role will be responsible to plan, direct, and manage the IT solutions for Clinical, Drug Safety, Regulatory, Medical Affairs and the Research and Development areas within Alkermes and provide leadership and knowledge empowerment for team members and mature the IT R&D services within the company. This role will be a key member of the IT Senior Leadership Team and will be the primary liaison between various internal and external IT organizations and the previously mentioned Alkermes functional areas. This position will report to the Chief Information Officer (CIO). This role will work a weekly hybrid office schedule in our Waltham location. Responsibilities Job...

Alkermes, Inc. In this leadership position, the Senior Director, Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes' growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work Duties and Responsibilities: Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical...

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...

Alkermes, Inc. The Associate Director, Competitive Intelligence (CI) will be part of a growing innovative team responsible for delivering actionable competitive insights to support strategic decision-making for both inline products and a late-stage pipeline asset. The Associate Director will partner closely with cross-functional teams, including Commercial, Medical, and R&D to reduce decision risk, and inform portfolio and product strategy. This role will be based in our Waltham office and work a Hybrid office schedule. Responsibilities Responsibilities: CI for Inline Products Monitor and analyze competitor activities and anticipate market shifts (e.g., marketing, pricing, clinical data, regulatory changes) to assess impact on company's commercial portfolio. Develop and maintain competitor profiles to support commercial teams and field force Deliver regular updates and alerts to stakeholders on market dynamics, competitor tactics, and threats/opportunities....

Revvity Overview: Revvity has embarked on a multi-year digital transformation journey to modernize our technology platforms and simplify our business processes. We are seeking an experienced VP, ERP Solutions to lead our global implementation and transformation of our Enterprise Resource Planning (ERP) platforms, including SAP S/4 HANA and Microsoft Dynamics. This high-visibility, high-impact initiative is a cornerstone of Revvity's digital strategy, designed to build a more agile, responsive, and efficient enterprise. Reporting to the Chief Digital and Strategy Officer, the VP, ERP Solutions will develop and lead the strategic direction, implementation, and optimization of Revvity's ERP ecosystem. This role will be accountable for driving business transformation through ERP modernization, managing resources, budgets, schedules, and risks across a global footprint. The VP, ERP Solutions will collaborate with business stakeholders, system integrators, and technology...