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- San Francisco, CA
new job!

Vice President, Regulatory Affairs San Francisco Bay Area Our client is seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance drug development program. The successful candidate will bring strong leadership abilities to oversee the Regulatory Affairs team, a successful history of effectively leading IND and NDA filings through approval, and interacting effectively with the FDA and other foreign regulatory bodies. This position....

- KS
new job!

overall accountability for and provides oversight to all aspects of operation of the Quality Assurance and Quality Control Lab departments and to serve as a site agent to manage compliance to all cGMP procedures, standards, and common practices. Supports development of the site business and quality plans.Ensures that all operations supporting quality control testing requirements for manufacturing are performed in a regulatory compliant manner.LeadershipLeadership to direct reports, including....

- Wyckoff, NJ
new job!

My client offers an outstanding culture and exceptional benefits, and they seek a Manager of Technical Writing to oversee a small group and take on the following tasks:Direct the overall process for creating, editing and publishing client reportsOversee variable workload by assigning and coordinating the work of othersEnsure the timely preparation of all manuscripts and responses to reviewer commentsServe as the internal editor-in-chief to establish and maintain a high-quality written....

- Boston, MA
new job!

Senior Electrical Engineer We are currently seeking an experienced Electrical Engineer to join our clients technical team. In addition to acting as the lead electrical engineer on projects, you will provide technical guidance to their junior design staff and have the opportunity to work on a range of projects.Position Responsibilities:Lead Electrical Engineer on projects.Responsible for production and review of narratives, drawings, and specifications for all assigned projects.Construction....

- Danbury, CT

Our client - a growing Pharmaceutical company located in the Danbury, CT area - is looking for a Validation Associate. The Validation Associate will be responsible for supporting all aspects of equipment qualification (IQ/OQ/PQ) as well as supporting process validation programs. The Validation Associate will be involved with creating and implementing various protocols as well as Final Reports. The qualified candidate will have 1-5 years of Pharmaceutical Industry experience - as well as some....


Job Description: We are seeking an experienced and determined professional with a passion for Project Management. As a consultant you will primarily work with clients in the pharmaceutical industry. You will engage directly with key decision makers and have the potential to create true impact. Tasks will mainly relate to Project Management of or within large investment projects. We are looking for a candidate with strong leadership and communication skills who is driven by a desire for....

- Cincinnati, OH

Job Description: Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management. The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving....


The positions serves as the site’s Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel. Job Functions: Demonstrates technical expertise in OSD technology and methodologies. Lead site related process development, scale-up, commercialization and tech transfer responsibilities Collaboratively develop project strategies....


Company is seeking a Principal Engineer to lead projects in the Biologics process development and clinical manufacturing projects. The individual will design, develop, scale-up and optimize drug substance and drug product unit operations for protein therapeutics. Experience managing projects from Discovery integration through GMP manufacturing, with both internal and external partners are required. The candidate should have strong technical, communication and interpersonal skills, be able to....

- Buffalo, NY

Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. - Review/approve deviations, OOS's, OOT's, EE's, and change controls. - Perform audits of the chem & micro labs. - Review/approve protocols, investigative studies, raw data and reports. - Establish and control quality programs to ensure conformance....

- Cincinnati, OH

The holder of this position is charged with leading effort to prove control of the critical aspects of company operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements. Subject matter expert in at least two main area of validation ( Process/Cleaning/Equipment /Utilities /Facilities/Computer Systems)Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understandingDetermine levels of....


This position provides technical leadership and accountability for computer system validation and ensures compliance with internal and external computerized system policies and regulations. As the Subject Matter Expert, this individual will ensure sites are fundamentally aware of and proactively implement current computerized system validation practices with particular focus on impact to patient safety, product quality and record integrity. Position scope includes local and global site systems

- Seattle OR San Fran, Cali, WA

Top tier Pharmaceutical company in Seattle, WA is expanding They are opening new office as well i nthe San Francisco Bay area of Califronia- this role can be located in either location Full benefits-medical/health, 401k and match, stock, LTis and STis...many progressive benefits...competitive compensation and bonus and more... Full relocation to either area The Sr. Director, Clinical Operations Program Management will be responsible for leading all aspects of clinical operations within the....


Top Tier Global Pharmaceutical Company is looking for a Supervisor for Print PRoduction= this is a w-2 contract (for one year and then up for renewal)- includes health, Medical benefits, vacation and more Company is in Jersey City and is moving to Madison, NJ in October (position sits in JC for now and then Madison) Oversees print production of promotional collateral from development to final distribution. Collaborates with creative agencies, marketing teams, and vendors to develop....


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....

- Petaluma, CA

Business Process Manager-Petaluma CA Dedicated to business process re engineering (analysis, mapping and optimization) to enable the routine delivery of exceptional business process performance. This position is within the Global Engineering and Facilities Services function of Supply Chain and supports operational improvement initiatives.). You will collaborate with Business Process Owners (BPO) to prioritize and drive business process improvements. The role reports into the Executive....


Top tier growing Global Pharmaceutical company is looking for a vibrant and sharp Manager of Regulatory Affairs to join their dynamic Team The is company has been named top new Pharma and one of the Best Employers in 2017 The role canbe in EITHER their Seattle, WA HQ or their NEW offices in San Francisco (full relocation package offered- And great benefits too) Must be a self starter with initiative and Regulatory Affairs experience in the Pharma industry- must have Regulatory affairs and CMC....


Top Tier Global Pharmaceutical company is expanding and looking for two Study Medical Experts (for Clinical) must be Medical Doctor with MD degree Can have experience in oncology or even internal medicine + endocrinology/rheumatology/gastroenterology/etc and have experience with research. Competitive salary and benefits and bonus, 401k, long term incentives and short term incentives and more Provide medical support for the study team:Global primary contact person during the course of the....


My client is expanding and looking to hire a Director for their Medical Affairs group. The ideal candidate will take on the following responsibilities:Direct collaborations with academic, pharma and biotech partners and facilitate work with biotech Directors and VPs, academic PIs, and others.Understand the research and drug development needs of existing partners and ensure exceptional service.Develop and expand research and clinical collaborations with new partners. The ideal candidate will....


My client is expanding and looking to hire a Director for their Medical Affairs group. The ideal candidate will take on the following responsibilities:Direct collaborations with academic, pharma and biotech partners and facilitate work with biotech Directors and VPs, academic PIs, and others.Understand the research and drug development needs of existing partners and ensure exceptional service.Develop and expand research and clinical collaborations with new partners. The ideal candidate will....

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