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- San Francisco, CA
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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....


Senior Director, Regulatory Affairs – Clinical Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with Clinical 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. ResponsibilitiesDirect and oversee short-term and long-term planning of regulatory submission....


Quality Assurance and Food Safety Manager Duties: The Quality Assurance (QA) and Food Safety Manager manage the Quality and Food Safety and programs. Oversight and monitoring of operational processes for compliance with policies and procedures to include, but not limited to, GMP, SSOP, HACCP, SQF, FSSC, and other regulatory and company pre-requisite programs, audits (internal and third party), and supporting company or customer QA programs. Close communication with production, purchasing,....


Associate Director / Director, Process Development – San Francisco Bay Area Responsibilities: Process Development of small molecule oncology drug candidates from research to validationSubject Matter Expert for process chemistry. Attend CMC meetings, provide status assessments and technical expertiseExperienced organic chemistry skills and leadership abilities to oversee outsourced projects at CRO/CMOCreate technology transfer, scale up and late stage supply chain strategy. Evaluate process....


TITLE: Blood Bank Network 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....


SR. GVP AUDITOR - San Francisco Bay Area RESPONSIBILITIESIndependently evaluate compliance of logistics and business partners with PV regulations: FDA, EMA, ANVISA and other relevant regulations under International Competent Authorities Plan, conduct domestic and international GVP audits to assess compliance to local and global government regulationsMust be able to work within a global team setting as well as an individual contributorPerform systems audits and due diligence reviews, identify....

- Bridgewater, NJ

My client is actively recruiting for a Director of Clinical Operations – this is a high profile position where the Director will be responsible for managing the clinical trial strategy in collaboration with the Medical Affairs Team, regulatory strategy and execution, publications strategy and plan. The ideal candidate will have clinical operations experience in pharma or biotech industries (in the oncology space.) The ideal candidate will take on the following tasks: --oversee clinical trials....

- San Francisco, CA

Outstanding opportunity for a Director of Quality for Clinical GCP. My client is seeking a talented Clinical Quality professional who has significant experience in ensuring that Clinical Trials are in compliance with Good Clinical Practice (GCP). Reporting in to the VP, this individual will be responsible for ensuring quality systems, procedures and documentation are in compliance with applicable US and international standards and regulations. While this is initially an individual contributor....


Senior Manager / Associate Director, Regulatory Affairs (Global / Oncology) – San Francisco Bay AreaCreate content and timelines of regulatory submissionsIdentify regulatory issues and provide solutionsLead content and publishing of documents for original INDs & NDAsLead efforts to produce an IND each yeaLead preparations for Regulatory Agency meetingsLead efforts to produce regulatory documentsCommunicate with global regulatory organizations to prepare applicationsAssure compliance with....


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....


Senior Clinical Data Manager, CDM - San Francisco Bay Area Responsibilities: Oversee clinical development activities and strategy executionsing the highest standards, manage the CD plan and the collection and interpretation of clinical dataContribute to the data preparation for reporting study results, regulatory submissions, and publicationsUse EDC Systems for data managementApprise management and project teams of clinical data activitiesContribute to the development and implementation of....

- 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 and has a need for three Principal (and Senior Principal) Medical Writers for their regulatory submissions. These are Full-time-employee positions- WORK FROM HOME- with strong compensation including full health, stock, bonus, long term and short term incentives and much more! This publicly traded global company is in a huge growth mode! Company plc (NYSE:XXX) is a bold, global pharmaceutical company and a leader in a new industry model –....

- Jersey City, NJ

Top Tier Pharmaceutical company in Jersey City, NJ needs a Senior Document Publisher- for aconsulting project (6 months and then up for renewal - can be 1099 or w-2 with benefits including health and PTO contract renewals up to 4 years- can go perm in future as well - contributes to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for his/her assigned products and/or therapeutic area(s)....


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....


Director, Regulatory Affairs / CMC A key leadership position in the therapeutic area of Oncology. Responsibilities include all development activities, marketed products, including CMC, labeling changes, and regulatory compliance of marketed products.Position requires a leader who can generate and effectively implement all strategic initiatives and programs, and communicate the status of all work to leadership and Board of Directors.The position is global in scope and will require the....


Top tier Pharmaceutical company (one n Boston and one in NJ nd one in Seattle)Required:Has completed management of a study or group of studies from planning through close out (Phase 3)Experience with managing VendorsExperience working on global studies with CROs Nice to Have:Experience supporting writing clinical study reports,Supporting sNDA or NDA submissions, Supporting pre-Inspection preparation,Participating in Sponsor Inspections by Regulatory BodiesExperience managing or leading teams....


Great career mobility with company experiencing fast-paced planned growth in a high-volume setting. This is a key management and leadership role. Must have prior supervisory and food-testing microbiology experience with bachelor or masters degree in microbiology. All applicants should have experience testing for microbes, bacteria, listeria, salmonella, and similar food contaminants. Overview Technical Manager oversees quality assurance systems and employee training for effective laboratory....

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