1-20 of 21 results
Sort By


Join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in....

- New Haven, CT

Overview Our client is seeking a Product Quality Assurance Team Leader who will provide quality oversight of new device and combination clinical products from introduction throughout the product and design control lifecycle. As the product quality expert, the Product Quality Engineer will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development, technology transfer, commercial operations, and product....

- San Diego, CA

MANAGER MEDICARE COMPLIANCE Location: United States - California - San Diego This position is located in Kearny Mesa, San Diego Required Skills and QualificationsBachelor’s degree in related field3 to 5 years’ of compliance experience within the health care industryWorking knowledge of Medicare Advantage regulations, resources and processesExperience designing, conducting and monitoring compliance auditsKnowledge of health plan operations and issuesStrong knowledge of compliance principles,....

- Cambridge, MA

Global Company is hiring a Senior Leader Clinical Operations Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications This position will be responsible for initiating and leading....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....


Drug Product Process Engineer Small Molecule Continuous process Improvement for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide....


We are looking for a Quality Assurance Document Control Associate to provide assistance with maintaining a GMP documentation system. General Responsibilities:Assist in implementing information systems for managing document tracking, controlled document distribution (issuance) and records management.Oversee the issuance and maintenance of logbooks.Facilitate the final review of production batch records.Assist in administering the change control system (issuance, tracking, and....

- Any US State

Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....

- Any US State

The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol, standard operating....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


Assist in the development of and implement the data management plan for clinical trials. * Pepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications. * Maintain traceability of data sets used for various reports. * Perform consistency checks and data cleaning functions. * Review data on a regular basis for trends and relationships. * Liaise with Clinical and Scientific research teams on data presentation. * Interact closely with....

- Harrisburg, PA

WHY YOU MIGHT BE INTERESTED This position will lead all site quality in QA and QC. This company is a well know on the world stage and is growing everyday. You will have 4 direct reports and about 30 indirect. WHAT WILL YOU DO IN THIS ROLEWorking with the global requirements to keep the Quality Management System in line with the local team. Department budgeting, personnel, investment planning for long-term objectivesWill work on all ISO Certifications in regards to cGMP compliance and auditsSet


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....

- Any US State

Global Pharmaceutical company is hiring Clinical Project Manager for their Clinical Development studies Day to day management of studies This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.Essential FunctionsThe Clinical Project Manager for this Pharmaceutical company- will:Utilize Project Management techniques and methodologies to plan,....


Global Pharmaceutical company is looking for a Clinical Partnership Liaison Must have pharmaceutical, Biotech or CRO experience at this senior level. located in NYC must work in the office three days/week The Partnership Liaison is a key leadership role within Clinical Operations Business Operations Management. The role is responsible for implementing and driving the success of the Clinical Development sourcing strategy. The role is accountable for Clinical Development alliances with clinical....


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....


The Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross-functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....

1-20 of 21 results