13 senior implementation project manager jobs found

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 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 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...

Merck Job Description This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements. Principal Responsibilities Lead/contribute to device...

Biogen Head of Medical Omnichannel, Digital, & Innovative Engagement North America Medical Job Description The Head of Medical Omnichannel, Digital, & Innovation Engagement will be part of the North America Medical Leadership Team and will develop and lead the Scientific & Value Communication function within North America Medical, serving as a strategic partner within Biogen to inform medical practice across our therapeutic areas and pipeline. Reporting to the Head of North America Medical, this high-impact position will implement cutting-edge strategies that integrate traditional scientific communications with innovative digital tools, artificial intelligence, and multichannel platforms. The successful candidate will shape our scientific narrative across Biogen's therapeutic portfolio while building next-generation capabilities that amplify our scientific impact and enable measurable patient outcomes. Through a cross-functionally accepted Scientific...

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...

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 Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

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 Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

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 SVP, Drug Safety and Pharmacovigilance, the Senior Director, is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent's products. Responsibilities: Safety Signal Detection, Evaluation, and Management...

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 SVP, Drug Safety and Pharmacovigilance, the Senior Director, is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent's products. Responsibilities: Safety Signal Detection, Evaluation, and Management...

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 Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations. This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related...

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 Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations. This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related...