19 senior product assurance manager jobs found in Cambridge

Biogen This position will be hybrid (3 days per week on site) and can either sit at our Cambridge MA location OR our Research Triangle Park, NC location About This Role The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization. What You'll Do Ensure quality and uninterrupted supply through the application of quality measures throughout the supply...

Biogen About This Role Biogen is preparing to launch an asset currently in development across multiple Nephrology indications.As the Director, Global Launch Excellence, Nephrology, you will collaborate with and guide cross-functional teams through key planning milestones to deliver impactful launch plans providing exceptional program management and developing launch frameworks that set the stage for future launches at Biogen. You will be accountable for leading cross-functional matrix teams to develop and execute robust launch plans, engage with internal c-suite stakeholders to provide launch progress updates, build and enhance organizational capabilities for launch via new methods, tools; and maximize launch excellence know-how across teams to enhance and accelerate decision-making. What You'll Do Collaborate as the primary Launch Excellence partner for the Global cross-functional Nephrology launch teams across Clinical Development, Regulatory, PO&T, Global...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role: As the Lead Deskside Support Analyst, you will be an integral part of the IT Deskside Services team, guiding all aspects of day-to-day incidents, tasks, and project delivery operations throughout the enterprise. This position requires you to help oversee onboarding support, equipment provisioning and deprovisioning, and provide deskside, labs, commercial, and VIP support. You will also manage onsite and offsite meetings and events, along with ServiceNow queue management. Serving as a technical mentor, you will offer training resources to internal and external team members, ensuring high customer satisfaction and smooth business operations. Additionally, you will document key deskside support processes, create training materials, and uphold support standards. Occasional travel may be required to provide support for external events, contributing to uninterrupted business operations and minimal escalations. What You'll Do: Serve as the one of the...

Biogen About This Role: We are seeking a Director of Advanced Analytics, Data Science & AI to spearhead efforts in generating and delivering data-driven insights that bolster a brand, therapeutic area, or cross-brand/enterprise initiatives, enhancing our innovative capabilities. Positioned at the heart of our strategic endeavors, this role involves influencing business partners, leading the execution and interpretation of AI/ML models, framing complex problems, and crafting compelling solutions. You will play a pivotal role in communicating clear and impactful data-driven insights across various teams. This dynamic and fast-paced position within a highly collaborative environment covers a broad range of strategic topics critical to our business success. To excel, you must possess an unwavering passion for data-driven problem solving, a robust background in data science and AI, and a track record of leading and developing high-performing teams that drive meaningful change...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Vice President, Commercial, The Vice President, Marketing will be a proven leader with deep expertise in oncology marketing, successful product launches, and team-building capabilities. This position will be responsible for developing and executing the brand strategy for zidesamtinib and neladalkib, potential best-in-class therapies for biomarker-directed NSCLC. The VP, Marketing will build and lead a comprehensive portfolio marketing plan while collaborating cross-functionally to ensure launch readiness. Responsibilities: * Develop and execute the brand strategy...

Biogen About This Role The Senior Manager, Insights & Analytics will play a critical role within the US Lupus team. You will be a proactive strategic thought partner for the US Brand team, responsible for driving actionable insights & deep understanding of the customer, overall market, and competitive landscape in both systemic and cutaneous lupus. This role plays a vital part in shaping the direction of the business and contributing to brand success. You will directly support the US Lupus brand team, focused on building foundational insights and building a go-to-market roadmap for one pipeline asset across multiple indications. You will provide critical insights for informed decisions, allowing for competitive positioning, and driving strategic initiatives based on an insights-driven approach. As a key partner to commercial and marketing leadership, you will help identify & address the most important business problems facing the franchise and help to develop...

Biogen About This Role The Governance, Risk & Control (GRC) Grants Team is dedicated to executing on Biogen's global grants and giving strategy, which aims to catalyze scientific innovation, addressing unmet patient needs and advance medical and disease education. The Global Grants Manager, Governance, Risk & Control, is critical to the department's success as they act as the primary support for the Senior Manager, Governance, Risk & Control for the Global Grants portfolio. Additionally, they will manage the Grants Customer Service for both internal and external stakeholders. What You'll Do Assist with the assigned portfolio of grants including request review, organization qualification, due diligence, decision communications, reconciliations, and refunds. Responsible for validating and reconciling all completed grants by confirming that funds were used appropriately, reviewing any material changes to the funded activities, and identifying any unused...

Biogen Reports to: Head of Strategy & Operations, Specialty (MS & Lupus) Job Description : The Associate Director of Strategy & Operations for the U.S. Specialty franchise plays a critical role in ensuring the organization is aligned, prepared, and operationally disciplined as we advance towards multiple lupus launches. Reporting to the Head of Strategy & Operations for Specialty, this role will partner closely with cross-functional leaders across Commercial, Medical, Access, and Commercial Operations to support strategic planning, meeting preparation, and operating rhythm execution. This position is designed to be the strategic operator and integrator for the Specialty (lupus-focused) business, driving day-to-day coordination, synthesizing cross-functional inputs, preparing high-quality executive materials, and ensuring timely execution of deliverables. Approximately 75% of the role is dedicated to Lupus, with ~25% supporting harmonized operational...

Biogen About This Role The Head of Scientific & Value Communications will develop and lead the Scientific & Value Communication function within the US Medical team, a strategic partner within Biogen, who helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. Through development and implementation of a cross-functionally accepted Scientific Communication Plan, the Head of Scientific & Value Communications will ensure consistent, compliant, and impactful communications via publications, congress activities and medical education. As such, this role is accountable for shaping the scientific narrative and leading all aspects of medical communications/publications' strategic and tactical planning, related to key company scientific data for presentation internally and externally. They will work closely with cross functional partners across US Medical, including but not limited to all US Medical therapeutic areas...

City of Cambridge ABOUT THE DEPARTMENT: The Department of Human Service Programs (DHSP) creates and coordinates services that enhance the quality of life for Cambridge residents. Driven by the needs of residents, DHSP's extensive services and programs touch almost every sector in the city: from newborns to senior citizens, from school-aged children to homeless families, from non-profit organizations to local employers. ABOUT THE ROLE: The Council on Aging (COA) is the "front door" of services and supports for older residents and caregivers. The COA offers a wide range of programs, activities, classes, and social services both virtually and in person at its two senior centers. The Food Services Manager will support the nutritional needs of older adults through the smooth operation of a congregate-based meals program and other events and programs that support the social well-being of seniors in Cambridge. A robust meals program is one of COA's strategies to encourage older...

Biogen Head of Nephrology, US Medical About This Role The Head of Nephrology, US Medical is a critical leadership role within the US Medical organization, accountable for the strategic direction and execution of medical affairs activities in Nephrology. This leadership role has ownership and accountability for the budget across data generation, management of access to, and utilization of external data bases and scientific research collaborations, scientific advisory boards, external scientific and medical engagements and field personnel management. The nephrology therapeutic area will span clinical trial support, early access programs, and lifecycle management studies, each supporting patients with high unmet needs and representing major growth opportunities for Biogen. This leader will oversee a cross-functional medical team including Medical Directors, Field Director, and Medical Science Liaisons (MSLs), while collaborating closely with Global Medical teams, Regulatory,...

Biogen About This Role The Associate Director, Data Science Lead, will play a pivotal role in Biogen's Data Science team, driving the development of advanced modeling solutions that inform strategic business decisions across Marketing, Sales, and Access. This role will be responsible for leading high-impact data science initiatives including marketing optimization, patient-level predictive analytics, machine learning-based personalization, and field force effectiveness strategies. As a hands-on contributor, you will guide and execute while collaborating with cross-functional teams to ensure that data science outputs are actionable, accurate, scalable, and aligned with brand priorities. You'll be a thought partner to commercial leadership, championing the use of data and AI to deliver measurable business value. What You'll Do: Execute flawlessly the long-term data science and AI vision, ensuring alignment with enterprise capability roadmaps, commercial priorities, and...

Biogen About This Role: As the Senior Director, Head of Immunology Communications, you will be in charge of raising awareness of Biogen's' rapidly expanding presence in immunology and driving strategic product communications plans for the franchise. Reporting to the Head of Global External Communications and Media, the individual is responsible for developing and executing internal and external multi-channel strategies that elevate Biogen's immunology portfolio, prepare the market in anticipation of multiple potential launches, and lead strategic execution of product communications plans. This role will have a specific focus on oversight and execution of product communications for its lupus franchise, while also being responsible for overseeing strategy for additional immunology assets, including in nephrology. This person will work closely with the Head of External Communications and Media on enterprise proactive storytelling around Biogen's growing leadership in...

Biogen About This Role: The Director of Strategy and Operations for the US Nephrology Franchise plays a crucial role in ensuring the team is optimally positioned to achieve strategic goals and business priorities. Reporting to the Head of the US Nephrology Franchise, you will serve as the chief of staff and a key member of the US Nephrology Leadership Team. This position involves establishing and managing a portfolio of strategic initiatives in collaboration with cross-functional leaders to drive innovation and alignment. You will guide the development and execution of the US Launch Strategy for nephrology assets, chair the US Launch Operations Team, and oversee a project manager for launch planning. Your influence will extend across project teams, providing matrixed leadership and advisory to enhance operational excellence. This role offers significant learning and development opportunities, requiring a combination of problem-solving skills, adaptability to fast-paced...

Biogen About This Role As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a critical part in ensuring the safety and efficacy of our products while fostering a collaborative and high-performing team environment. What You'll Do Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight. Oversee signal detection and management activities, Risk Management Plans (RMPs - core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs). Demonstrate leadership and interact collaboratively and effectively in a team environment including Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues. Respond to regulatory requests and support regulatory filing activities for topics and questions related to product...

City of Cambridge ABOUT THE ROLE : The City is currently seeking an architectural design or construction management professional with 5+ years of experience to join our team as Senior Capital Project Manager in the Capital Building Projects Department. The Capital Building Projects Department is a new department that consolidates existing programs from the Executive Office and Public Works Department, along with new positions, to continue to deliver high-quality professional management of the City's expanding building improvement project portfolio. The Capital Building Projects Department includes eight full-time employees, working under the new position of Director of Capital Building Projects. Major program areas include design, construction, and system performance. This organizational structure will ensure that consideration of strategic priorities such the Net Zero Action Plan and the Building Energy Use Disclosure Ordinance is embedded in all aspects of project...