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Senior Clinical Data Manager, CDM - San Francisco Bay Area Our client, a progressive biopharmaceutical company with multiple trials in Phase I-III, has a new opportunity for a Senior Clinical Data Manager professional with oncology expertise in the San Francisco Bay. This person will drive and manage Clinical Study data. This is a full-time, onsite, senior role with a primary focus on the discovery and development of oncology drugs. The ideal candidate be an integral part of a team of....


SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle. Senior....


ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a global pharma company, has a new opportunity for an Associate Director / Director level Regulatory Affairs professional with CMC expertise in Central NJ, to help drive US and Global Regulatory projects. This is a full-time Associate Director / Director level role with a primary focus in small molecule development. Independently manages all regulatory CMC business for drug candidates/products throughout lifecycle. Associate....


Job Description: Establishes and monitors Quality Assurance and Regulatory Affairs procedures and activities. Ensures the enrollment and participation of the Clinical Laboratory in an approved proficiency testing program for all tests performed. Design, implement and maintain Quality Metrics. Performs other duties as assigned. QUALIFICATIONS: Education/Skills: B.S. Degree in Medical Technology or educational equivalent. Licensure: MT or equivalent. Experience: A minimum of one year recent....


Global Pharmaceutical client needs a 12-24 month contract worker for their Gastroenterology (GI) team. Minimum RequirementsRelevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the Gastroenterology preferredAt least 4 years of clinical/research experience in the pharmaceutical/device industryAbility to travel up to at least 10% of time, including international travelAuthorization to work for any employer in the US (without sponsorship)Description The Senior....

- Indianapolis, IN

TITLE: Blood Bank Administrator LOCATION: Indianapolis, IN Are you considering a career change? Would you be interested in living in a large city that doesn't feel like it. The Indianapolis area has something for everyone. If so, an opportunity to work an established organization that serves several locations in Indiana is looking for someone to join their team. Summary The Blood Bank Network Administrator assists in development of data-driven pre-analytical, analytical, and post-analytical....


Directs the regulatory process for both US and Canada governmental approvals ensure necessary documentation is filed and all government interactions are handled appropriately. Develops processes and procedures to ensure regulatory compliance and provides sound risk assessments with regards to changes in animal health manufacturing processes.Completes submissions and internal assessments for regulatory reviewsParticipates in FDA audits and correspondences; for regulatory needs, acts as primary....


Charged with the procedures and activities of Quality Assurance and Regulatory Affairs. Tracks and monitors the Clinical Laboratory and ensures all procedures are approved and efficient. Design, implement and maintain Quality Metrics. Performs other duties as assigned. QUALIFICATIONS: Education/Skills: B.S. Degree in Medical Technology or educational equivalent. Licensure: MT or equivalent. Experience: A minimum of one year recent laboratory related experience required. Min of 1 yr. quality....

- Newark/Princeton Area, NJ

Our client, a Fortune 150 Medical Diagnostics Equipment Manufacturer, is looking for a Senior QA Auditor to join Division Team in Central New Jersey area and independently conduct assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Corporate Quality System requirements across multiple Plants within Division. Participate in audits of manufacturing and commercial affiliate sites.in US and CanadaManage and/or participate in....


Responsible for strategically planning and directing all business development initiatives, policies, and objectives for assigned foreign markets. Manage to execution all major strategic decisions to increase global market share and sales figures. This is not a sales position, its more of a support role. Need someone that can create international material. Roles and Responsibilities: With management goals, helps to define the International Division’s short and long-term business strategies and....


Top Tier Global Pharmaceutical company is expanding – Looking for a Director, Clinical Devlopment in their New Jersey office (Jersey City or Madison, NJ) – Supporting their GI programs (Phase III Diabetic Gastroparisis); role will sit in JC for the short term. (Ultimately Madison, NJ). The role will require a MD (GI preferred not required) Must have GI clinical development experience (4-5 years will be sufficient) Will lead and develop Phase III GI program This will be an exciting opportunity....


Our client, a major Pharmaceutical Company in the Central NJ area, is looking for a Sr. Mgr./Associate Director - Regulatory Affairs. The Sr. Mgr./Associate Director Regulatory Affairs will oversee a variety of projects (IND/NDA/BLA), and they will manage these projects through all phases of development as well as be involved with both post-approval and life-cycle management issues. The Sr. Mgr./Associate Director Regulatory Affairs will:Develop regulatory strategiesProvide regulatory....

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