82 project manager jobs found

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Collegium Pharmaceutical Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW The Manager, Internal Communications will help inform, engage, and inspire employees across the organization. This role is responsible for day-to-day internal communications strategy and execution, including ownership of the company intranet, cross-functional messaging, employee engagement moments, and select executive communications support. The ideal candidate is a strong writer and project manager who enjoys building structure, partnering with HR and business leaders, and creating content that brings our culture and strategy to life. RESPONSIBILITIES Internal Channels & Content *...

Biogen About This Role The Senior Manager, US Forecasting will be an integral part of the Decision sciences- Forecasting Center of Excellence team and will assist in developing and maintaining the forecast models for the US business for Biogen North America Franchises, leveraging both primary and secondary data assets to drive accurate predictions and providing valuable insights for strategic planning and resource allocation across multiple indications. The individual will work cross-functionally to gather inputs for the forecast, socialize outputs, and run sensitivities and ad hoc analyses. The individual will help the business build objective and fact-based forecasts and scenarios that enable the business to make data-driven decisions that maximize shareholder value. The role offers a mix of analytical, strategic, and operational work and the opportunity to collaborate with a wide array of stakeholders at various levels to help drive business success. The individual will...

Biogen About This Role As a Principal Application Specialist, you will play a critical role in designing, building, implementing, and maintaining Veeva Vault Document Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault QualityDocs is a critical component of this transformation, and you will be the ultimate driver, leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault QualityDocs, you will collaborate closely with cross-functional teams, including business analysts, technical architects, system configurators and project managers, to deliver upgrades, enhancements, new modules, and other initiatives aligned with strategic business roadmaps. Your work will directly support Biogen's Employee Experience and GxP compliance, ensuring that our document management system meets regulatory requirements and user...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Biogen About This Role: As Biogen's Access Management Service Delivery Manager (SDM) you are the Access Management subject matter expert and services leader for all Access Management activities at Biogen. This role is accountable for delivering value to global stakeholders - which includes access services to every application in Biogen. A peer to this role is the Service Delivery Manager of Identity. This role is a direct report of the Global Leader of Identity and Access Management and is a member of the extended leadership team within the Cybersecurity organization. As Access Management SDM, you are responsible for establishing access management policies and standards and keeping them current. You are responsible for the planning and execution of initiatives that improve access management capabilities - both central platforms or efforts supporting independent stakeholder applications. This role is responsible for the entire service delivery process, from planning and...

Biogen 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. In alignment with established procedures and SOPs, the Senior Manager, CTL, leverages their phase, indication and operational expertise to independently oversee one or more clinical studies, including: Partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient focus, risk management, quality and scientific integrity are applied, exercising appropriate budget responsibility and focused, endpoint-driven cost consideration Developing and implementing the study-level operational strategy, cascading key operational aspects from the Integrated Development Plan and...

Biogen This position is hybrid to our Cambridge MA location and requires frequent on-site presence About This Role: As the Associate Director, US Forecasting, you will be a vital member of the Decision Sciences - Forecasting Center of Excellence team, tasked with developing and maintaining precise forecast models for Biogen North America's franchises. Your expertise will drive accurate predictions using both primary and secondary data assets, offering valuable insights for strategic planning and resource allocation across multiple indications. This role involves cross-functional collaboration to gather inputs, socialize outputs, and execute sensitivity and ad hoc analyses. You will empower the business to build objective forecasts and scenarios that enable data-driven decisions, maximizing shareholder value. Reporting to the Senior Director, Forecasting COE, this position offers a blend of analytical, strategic, and operational work, allowing you to engage with stakeholders...

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 Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

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 Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Collegium Pharmaceutical Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW The Manager, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR *210, *211, and *820 cGMP. This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Batch Disposition, Investigations (Deviation / Product Complaint), CAPAs, Change Control, etc. ) that allow the company to maintain all licenses to operate. This individual will be critical in supporting interdepartmental and cross functional project...

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 Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

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 Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function: This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic alignment. Determines Submission Sciences support model and resource allocation. Supports IT initiatives including acquisitions, divestitures, software upgrades, and new software solutions Develop and...

Biogen As the Pharmacovigilance Agreement (PVA) Senior Manager, you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning, visualization, and archival systems required for on-time development and marketed product SDEAs, PV transfer agreements, and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogen's product pipeline and portfolio. What You'll Do Conduct timely outreach for SDEA planning, authoring and stakeholder and corporate partner transparency Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports Act as an SDEA subject matter expert for audit and inspections and SDEA inbox...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director of State Policy for the State Advocacy team. The Director will play a pivotal role in shaping policies that protect and promote the discovery, development, and delivery of medicines to help patients live longer and healthier lives. Reporting to the Deputy Vice President, you will develop and lead the policy-related strategy for key midwestern states, including Ohio, Indiana, and Kentucky. You’ll have the resources and support you need to be effective on key issues, including Medicaid, insurance, cost/value, 340B, and prescription drug pricing. In this highly visible, fast-paced role, you will collaborate with colleagues across PhRMA, engage with stakeholders at more than 30 member companies, and represent PhRMA at state legislative and regulatory hearings and other stakeholder meetings. You’ll apply your expertise in relationship building and communication to inspire confidence...