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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....


Job Category: Research & Development The Senior Clinical Program Leader I3 (Inflammation, Immunology and/or Infectious Disease) is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA).You provide the primary interface between the I3 DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line....


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....


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....

- 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....


Data Scientist - Precision Medicine My client is a rapidly growing biotech firm with cutting-edge technology and product portfolio for protein biomarker discovery and development. They seek a Data Scientist to collaborate with the global data science group and provide innovative solutions. The ideal candidate will take on the following tasks:Provide data analysis support and lead in the design, analysis, and interpretation of translational research experiments for internal and external....

- New York, NY

My client is in start-up mode seeks a Director to oversee clinical research and drug safety activities along with clinical research strategy. The ideal candidate will take on the following tasks:Oversee clinical study activities.Recruit, manage and develop a small clinical research and drug safety team.Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, and assist with manuscript preparation.Forecast....


Top Tier Pharmaceutical Company hiring Cardiologist Field Physician or Senior Field Physician Cardiology A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified cardiologist who has a history of clinical practice, who has significant experience in the therapeutic area of cardiology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant experience in their....


Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....


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....


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,....

- 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....


Pharmaceutical company seeking a Quality Control Chemistry Associate I or II for a position based at their Cambridge, MA site initially with a planned move to Norwood, MA in the May/June timeframe. The individual in this role will perform routine testing of raw materials and samples for mRNA products (in process, release and stability) manufactured at the Norwood, MA facility. Also, this individual may support special projects as assigned. He/she will participate in troubleshooting assays and....

- Norwood, MA

Manufacturing Associate (five needs) 1st and 2nd Shifts available 6 month contract, and renewable up to 4 years Company is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will eventually transition from Cambridge, MA to our new GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials.


Global Pharmaceutical company is hiring a Director, Scientific Communications- VERY COMPETITIVE base salary, bonus, stock and other Long Term Incentives Succesfull Pharma with marketed products and pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Company has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing....


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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