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Outstanding opportunity for a Corporate Environmental Management Director, who will be responsible for providing strategic leadership and direction in the planning, development, implementation and evaluation of the environmental affairs for the Global Chemical Leader. You will be responsible for establishing the vision, strategy and execution of environmental programs and management systems to identify and minimize environmental risks and liabilities ensuring compliance with all applicable....

- 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,....

- Los Angeles, CA

Assist in the development of and implement the data management plan for clinical trials. Develop and produce routine reports for internal and external circulation. * Prepare 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....


Medical device manufacturer in E.TN has immediate need for a Regulatory Affairs Specialist. Will prepare global regulatory submissions and work closely with product development teams to ensure compliance. The Regulatory Affairs Specialist is responsible for developing and reviewing submissions, documentation, labeling, and procedures for compliance with 21 CFR 820, EU 2017/745 and other regulatory standards. The Regulatory Affairs Specialist will maintain licensure for Pharmaceutical....


Leading Pharmaceutical Company with marketed products and strong Neurology Pipeline is looking for a Director, Medical Information for their growing US Headquarters in Waltham, MA Competitive Base, Bonus, Long Term Incentives and Relocation The Director, Medical Information (MI) will be responsible for leading the MI function within the Medical Affairs. The Director, Medical Information will be responsible for managing the member of the MI function who are providing and supporting the....


The Senior Manager Clinical Operations 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 Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


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....


Global Pharmaceutical company which focuses in Rare Disease, Oncology and Infectious Disease is hiring a Biosmaple Operations Manager Must have GCP experience and Sponsor experience (Biotech or Pharmaceutical) One year w-2 contract with full benefits offered Or can go permanent Full time Send resume if interested and qualified:Company is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay....


Position Overview The Director Real World Evidence Analytics ensures that real-world evidence (RWE) studies and queries are strategically designed and optimally executed to the highest standards. This research includes data management, programming, and statistical analysis of health claims, electronic medical records, and other observational data sources. The Director also keeps current with healthcare policies, RWE data trends Biopharmaceutical industry, and other developments with other....


We are seeking a dynamic medical affairs professional with leadership qualities to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry (schizophrenia). In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for the program....


Director, Medical Information 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 experimental design with a focus on process....

- Greenville, SC

Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing....


We are looking for a Quality Assurance Document Control Associate to provide assistance with maintaining a GMP documentation system. Roles And ResponsibilitiesAssist 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....


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....

- Tacoma | Seattle, WA

VP of Compliance - Seattle/Tacoma ________________________________________________ Leading healthcare enterprise - excellent team work - generous relocation package. Experienced leader and relationship -builder with a successful career in health plan compliance will have an opportunity to continue the already successful programs and contribute to the continued growth in this market. The VP will work as a partner to the CEO. VP will serve as a key part of the local leadership team ensuring....


Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....


Senior Clinical Research Associate Norwood, MA - No Remote Option Competitive Pay, 8% bonus, 6% 401k, 4 weeks PTO Relocation assistance available Every year, healthcare systems run millions of clinical tests to help identify the causes of certain symptoms their patients are experiencing. The Point of Care marketplace is rapidly growing/evolving, with cutting edge technology, machines, and rapid testing solutions at physicians fingertips. We have a unique opportunity (newly-created, to support....

- Palo Alto, CA

The Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple company portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and....


Global Pharmaceutical Company with Animal Health Division is expanding the Manager of Health & Safety/Environmental/Security is responsible for managing the work activities of exempt and non-exempt staff whose focus and responsibilities include assuring that Clinton Laboratories operates all of its activities in a manner that meets all state, federal and company HSE and security standards. This individual works closely with the other management leaders of the site as well as the corporate....


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....

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