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- 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....

- Madison, NJ
new job!

Global Pharmaceutical company in Madison, New Jersey is looking for a Senior Biostatistician NE DAY ONSITE IN MADISON ONLY IS REQUIRED AS PER MANAGER. Job Description: Responsible for the activities of Biostatistics for one or more therapeutic area to ensure that Company Medical Affairs clinical trials are correctly designed, properly analyzed and clearly presented to support post marketing product strategy and publication development. Act as project Biostatistician to provide bio-statistical....


Global Pharmaceutical company in Northern New Jersey is expanding and looking for a Snr Clinical Operations Pharmacology Associate for a w-2 long term contract SR. Clinical Operations Associate- Clinical Pharmacology - Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out - Ensure timely execution of studies in accordance with GCP and Allergan’s SOPs. - Assist in development of case report


Title: Senior Project Manager, R&D Project Management CNS For Madison, NJ location Contract R&D Project Planner III POSITION SUMMARY: The Contract R&D Project Planner is responsible for supporting Clinical Trial/Project Teams by strategically developing and maintaining clinical study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. This person will work in a....

- Seattle OR San Fran, Cali, WA
new job!

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 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....


Relocation assistance to Tulsa, OK approved for this position. Key requirements for candidates: - Experience in New Product Development quality aspects for medical devices - Able to deal at high level across technologies that might be out of his core competencies - Awareness of international medical standards and regulations - Risk management for medical device (14971) - Ability to work in great autonomy since remote from the rest of the team - Engaging and communicating effectively. Other....


Join a global leader as a Eco-Toxicologist responsible for conducting quantitative environmental risk assessments for agrichemical and fertilizer products and traits in North America. You will provide technical advice on study designs for regulatory and research oriented studies as well as advice to support new and existing registrations of client products and traits. --- Work closely with regional/global regulatory and product safety teams as well as other functional teams to produce risk....

- Suburban Detroit, MI

Overview: The QA Director is responsible for the overall management of the quality assurance systems and related activities. This includes upholding and improving the quality management system and to promote both the awareness and adherence to customer and regulatory requirements.Top Accountabilities: 1. Ensure that the quality system processes and products comply with Federal and International Regulatory requirements. i.e., (ISO 13485/MDD, CMDR, FDA QSR). 2. Lead the maintenance and....


Top tier Pharmaceutical company Clinical Operations is critical to the success of Company’s R & D strategies; our team is expanding and seeks a Study Team Leader to continue our growth in novel cellular immunotherapies. You will be responsible for study team management for phase 1 – 3 gene therapy trials in hematology oncology arena, the planning and execution of complex clinical trial in accordance with corporate timelines, and assist in the conduct of clinical trial activities, in....


Accountability Objective: Responsible for the completion of assigned US Regulatory Submission and Compliance activities the company and its designated suppliers; coordinate assigned US and OUS regulatory reporting, such as MDRs, Vigilance Reports, Clinical Progress Reports, and Post-Approval Reports; provide support for: US and OUS regulatory submissions of new and existing products marketed by the company; assure compliance with US and OUS international regulatory requirements for Class III....


NO RELOCATION ASSISTANCE Summary: Fast growing division of a global medical device leader is for a Regulatory Affairs lead for new product introduction and support existing products. Requirements:Bachelors degree3-8 years experience with 510(k), CE-Marking and other Regulatory market approval submissions for Class II and III medical devicesGlobal regulatory submission experience highly preferredExperience working new products from initial development through commercializationExperience....


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....


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....

- Any US State

Validation Manager To manage all validation activities at the plant. This includes but is not limited to facility, equipment, cleaning, computer and process validation. This position will lead the site to ensure compliance to all applicable regulations and requirements. Ensures implementation of compliant validation master plan for the site and ensures all activities within the master plan are planned and executed. Writes, reviews and executes any required validation protocols to ensure....


DIRECTOR / 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.....


Top Tier Progressive Bio Pharmaceutical company with offices in Seattle and San Francisco is expanding They are looking to hire a Director of Regulatory Advertising and Promo Description Company rates #1 in Northwest! They are a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune....


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....

- Any US State

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....


This is a key position that will have product development oversight responsibility for Design Control as the product moves through the development stages to commercialization. Key liaison between Product Development, Quality Engineering, and Regulatory Affairs. Maintain focus on VOC requirements as defined by Marketing. Required Background & Experience:MEDICAL DEVICE PRODUCT DEVELOPMENT EXPERIENCEBS degree in a technical discipline, preferably engineering. Advanced degree is a plus.Strong....

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