18 lead independent testing officer jobs found

Merck Job Description This position will contribute to our Company's drug discovery and development efforts in the Drug Metabolism and Pharmacokinetics (DMPK) Group within the Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) organization at our Research & Development Division in South San Francisco, CA. Candidate will primarily perform lab-based activities and be responsible for generating in vitro DMPK data to guide lead candidate optimization and development efforts. Candidate will have the opportunity to work closely with scientists across the network. They will leverage novel tools and emerging technology to evolve our approach. Embedded in our Company's network, this role will facilitate the seamless transfer of protocols and data across platforms to advance our scientific strategy. Successful candidate will impact projects across therapeutic areas through their passion for generating high-quality data. The ideal candidate will exhibit strong...

Merck Job Description Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. We are seeking a highly motivated Senior Scientist with a strong laboratory automation skill set to join the Translational Sciences and Outsourcing group at West Point, PA in the area of automation. We are looking for a highly motivated candidate with experience in advanced analytical method...

Merck Job Description Associate Principal Scientist - Continuous & Expression Technologies in Large Molecule Downstream Processing The Continuous & Expression Technologies (CET) Group within the Process Research & Development, Enabling Technologies department is seeking motivated and creative individuals. This is an opportunity to positively impact our company's manufacturing platforms, while actively supporting drug development in the biologics and vaccine arenas. Specifically, CET is seeking an Associate Principal Scientist specializing in bioprocessing purification technologies for multiple therapeutic classes - at our site in Rahway, NJ. Our Scientists are our Inventors. As a member of the CET Group, you will drive scientific innovation and critically evaluate opportunities to implement enabling technologies. We are seeking a collaborative, self-directed learner with a penchant for problem-solving and expertise in downstream bioprocessing to join the...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for early oncology studies. The incumbent is responsible for the design and...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for early oncology studies. The incumbent is responsible for the design and...

Merck Job Description Associate Specialist - MACS Operations Specialist (P1) Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Operations Specialist include the following: The Operations Specialist role at the Associate Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry...

Merck Job Description Associate Specialist - MACS Operations Specialist (P1) Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Operations Specialist include the following: The Operations Specialist role at the Associate Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry...

Merck Job Description Focus Area: Respiratory - Steroid free medicine Our Marketing team is passionate about bringing our medicines and vaccines to our customers around the world. Through digital listening and patient analytics, we are able to understand our customers' needs and strive to provide solutions to meet them. At our Company, we are leveraging insights, analytics and technology, as we invent for life on behalf of patients around the world. We are seeking those who have a passion for using strategic insights, data and analytics to drive decision making, that will allow us to tackle some of the world's greatest health threats. Within our Digital Human Health organization, we are transforming to better power decision-making across our end-to-end commercialization process, from business development to late lifecycle management. As we endeavor, we are seeking a dynamic talent for the role of Associate Director, Primary Market Research Position Description:...

Merck Job Description Focus Area: Respiratory - Steroid free medicine Our Marketing team is passionate about bringing our medicines and vaccines to our customers around the world. Through digital listening and patient analytics, we are able to understand our customers' needs and strive to provide solutions to meet them. At our Company, we are leveraging insights, analytics and technology, as we invent for life on behalf of patients around the world. We are seeking those who have a passion for using strategic insights, data and analytics to drive decision making, that will allow us to tackle some of the world's greatest health threats. Within our Digital Human Health organization, we are transforming to better power decision-making across our end-to-end commercialization process, from business development to late lifecycle management. As we endeavor, we are seeking a dynamic talent for the role of Associate Director, Primary Market Research Position Description:...

Merck Job Description Focus Area: Respiratory - Steroid free medicine Our Marketing team is passionate about bringing our medicines and vaccines to our customers around the world. Through digital listening and patient analytics, we are able to understand our customers' needs and strive to provide solutions to meet them. At our Company, we are leveraging insights, analytics and technology, as we invent for life on behalf of patients around the world. We are seeking those who have a passion for using strategic insights, data and analytics to drive decision making, that will allow us to tackle some of the world's greatest health threats. Within our Digital Human Health organization, we are transforming to better power decision-making across our end-to-end commercialization process, from business development to late lifecycle management. As we endeavor, we are seeking a dynamic talent for the role of Associate Director, Primary Market Research Position Description:...

Merck Job Description Focus Area: Respiratory - Steroid free medicine Our Marketing team is passionate about bringing our medicines and vaccines to our customers around the world. Through digital listening and patient analytics, we are able to understand our customers' needs and strive to provide solutions to meet them. At our Company, we are leveraging insights, analytics and technology, as we invent for life on behalf of patients around the world. We are seeking those who have a passion for using strategic insights, data and analytics to drive decision making, that will allow us to tackle some of the world's greatest health threats. Within our Digital Human Health organization, we are transforming to better power decision-making across our end-to-end commercialization process, from business development to late lifecycle management. As we endeavor, we are seeking a dynamic talent for the role of Associate Director, Primary Market Research Position Description:...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our Company Biostatistics and Research Decision Sciences (BARDS) group. The senior statistical programmer utilizes multiple programming languages including SAS and R to efficiently manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer clinical...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our Company Biostatistics and Research Decision Sciences (BARDS) group. The senior statistical programmer utilizes multiple programming languages including SAS and R to efficiently manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer clinical...

Biogen About This Role: As the Executive Assistant to the Head of Research, you will be an integral part of our research leadership team, providing high-level administrative support and coordination. Your role will involve managing various crucial tasks such as organizing efficient communication, handling confidential information, and prioritizing multiple activities to ensure the smooth operation of the department. You will also collaborate with other administrative and operations staff to coordinate large site-level activities. Your contributions will help drive the success of our research initiatives and maintain the department's seamless integration into the overall business structure. This position requires a blend of professionalism, urgency, and the ability to handle sensitive material with the utmost discretion. If you are highly organized, agile and able to multi-task, comfortable with change, and have a background in projects or event coordination in the biotechnology...

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...

Biogen About the Role: This application is for a 6-month student role fromJune-November2026.Resume review begins inOctober2025.This role is recruiting for multiple openings. The Biogen Internal Audit department is an independent assurance function that assists the Company in assessing the reliability of financial reporting, compliance with applicable laws, regulations and company policies, and the efficiency and effectiveness of business operations. You will function as an integral part of audit teams, working under the direction of the auditor-in-charge, to meet the objectives of audit activities within established deadlines. What You'll Do: You will focus on assessing the operational effectiveness of financial controls (i.e., Sarbanes-Oxley 404 testing) along with other members of the Internal Audit team but may also participate in other audit projects as needed. This work may include: Test the design and operating effectiveness of Sarbanes-Oxley controls...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for its Law team who will serve as in-house legal counsel advising on state laws, legislation, and regulations that are of import to the biopharmaceutical industry, its members, and the patients it serves. Reporting to the Senior Assistant General Counsel/Head of State Legal Affairs. The Sr. Director will: Serve as legal counsel for state law issues, including but not limited to prescription drug affordability boards, health insurance benefit design, and litigation and administrative law issues; Provide and coordinate support to PhRMA’s State Advocacy and Policy & Research teams; Advocate on behalf of PhRMA and its members to state and local legislative and regulatory bodies; Coordinate legal issue alignment with member company in-house counsel; Manage and supervise external counsel on issues relating to state laws, legislation and regulation, and litigation...

Fusion Pharmaceuticals Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet...