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- 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....

- San Diego, CA
new job!

Op Ex Manager Looking for an OP EX Manager for a medical diagnostics company in San Diego. You must have managed a continuous improvement program. Will lead process improvement projects across a wide spectrum at the company's flagship site in San Diego, CA. The Continuous Improvement Specialist will develop, lead and manage Lean Six Sigma - LSS - initiatives, driving operational excellence and a continuous improvement culture. The Continuous Improvement Specialist will have the opportunity to....

- Petaluma, CA
new job!

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....

- 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....

- Columbus, OH
new job!

My client seeks a manager to assist with educating physicians in academia and teaching hospitals. The ideal candidate will take on the following tasks:Create and deliver training programs for new physicians in electrophysiology, interventional cardiology, heart failure, general cardiology and surgeryEducate clients on the clinical evidence demonstrating efficacy of the productPartner with internal leadership to help create road map to expand utilizationDrive adoption by developing consultative

- Charlotte, NC
new job!

My client seeks a manager to assist with educating physicians in academia and teaching hospitals. The ideal candidate will take on the following tasks:Create and deliver training programs for new physicians in electrophysiology, interventional cardiology, heart failure, general cardiology and surgeryEducate clients on the clinical evidence demonstrating efficacy of the productPartner with internal leadership to help create road map to expand utilizationDrive adoption by developing consultative

- Cincinnati, OH
new job!

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....

- Cincinnati, OH
new job!

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

- Cincinnati, OH
new job!

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
new job!

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....

- Northern Atlanta area, GA
new job!

System Engineer- Atlanta GA Our client, a worldwide leader in diagnostics products ise seeking a System Engineer with strong product development experience to join their Systems Engineering Department at corporate headquarters in Atlanta, GA area. As an engineer in the systems engineering group, you will be a key problem solver and team member of cross-functional new product development projects from concept to manufacturing. You will use expert technical skills to execute R&D product....


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....


Position: Gastroenterology Hospitalist Location: Tucson, AZ Our client is seeking a Gastroenterology Hospitalist to join their established practice in beautiful Tucson, Arizona. Physicians can expect to enter a practice with high patient demand and a loyal patient base, in an expanding suburban market. The culture is one that values open communication and feedback from its physicians. Preferred candidate will have three (3) to five (5) years' experience and be BE/BC. Also, will consider new....

- San Francisco, CA

Our client in the San Francisco Bay area, has a new opportunity for Medical Director with expertise in Oncology NGS. This is a full-time, onsite position, with the opportunity to make an impact, company is seeking a driver to lead change. Medical Director, Oncology NGS San Francisco Bay AreaServes as company’s internal and external oncology / medical expert collaborating with several departments / business units including marketing, market access, salesRespond to questions from physicians and....


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....

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