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- Any US State
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Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....

- Pleasanton, CA
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Our large drug/device combo client in Irvine, CA needs a temporary Regulatory Affairs Associate. This contract is estimated to last 12 weeks. This person will coordinate most aspects of company regulatory activities and may interface with domestic and international health authorities. Qualifications: - BS or BA degree, 1-3 years of experience in regulatory affairs. - Experience in a company start-up environment, preferably in medical devices or combination products. - Knowledge of FDA, CA-FDB,

- Seattle OR San Fran, Cali, WA
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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....


Our large pharma client in Irvine, CA is in need of a Sales Analyst on a temp to hire basis. We are one of the few agencies that pays 65% of health insurance costs. MINIMUM REQUIREMENTS: - Bachelor's degree in Business, Computer Science, or Information Technology, Healthcare or related experience preferred. MBA Preferred. - A minimum of 2 years of experience as an Analyst, preferably in a Finance, Sales or Marketing business environment - Advanced Excel Skills are a requirement - Experience....


The Lead Control Systems engineer is responsible for control systems design, specification, programming, simulation and testing, and start-up assistance. Often, this person will be the project technical lead and may be responsible for some project management activities. Design responsibilities include requirements definition, functional and detailed design documentation development. Testing responsibilities include factory and site acceptance test development and execution. Programming....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....


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....


Sr Automation Engineer Job Description: As a member of the Engineering and Facilities Reliability Automation team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem solving techniques, project management, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, design, installation and lifecycle management of....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....


Reporting to the Executive Director of Early Development this physician will serve inside the medical sciences group as a leader in Hematology/Oncology early development. This Oncologist will lead early phase clinical development of oncology compounds from first-in-man studies through proof of concept. They will define, design, and execute early phase clinical and translational projects as the initial strategy for drug development. This physician should be trained in Oncology and have....


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


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....


Senior Regulatory Affairs Specialist (Medical Device) Newark, DE (Relocation Assistance Provided) Competitive Base Salary, Bonus 10%, 6 401K Match, Full Benefits, 4 weeks PTO We have a newly created opening for a Senior Regulatory Affairs Specialist position with a longstanding client; multi-billion global medical instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that....


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....

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