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- 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....


Executive Director, Global Oncology Medical Affairs. Reporting the Chief Medical Officer, the Executive Medical Director will be accountable for the development and execution of the global medical affairs strategy. This physician will develop and lead the execution of global external engagement, communication and evidence generation strategies and will contribute to the overall global product strategy.This role is for a physician with at least ten plus years of oncology medical affairs....

- Elmsford, NY
new job!

Staff Biostatistician (Or Senior Staff - Depending on Level of Experience) East Coast (NY, NJ, or DE) Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized,....

- Newark, DE
new job!

Staff Biostatistician (Or Senior Staff - Depending on Level of Experience) East Coast (NY, NJ, or DE) Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized,....

- Madison, NJ
new job!

Top Tier Global Pharmaceutical company in New Jersey is expanding: Looking for a strong Professional with Regulatory and Associate Director, Analytical Development bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. we are focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. We market a portfolio of best-in-class products that provide novel treatments for the central nervous....


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....

- 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....


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....


Are you a BC MD or DO BC by an Approved ABMS Board preferably in a primary care specialty (Internal Medicine, Med/Peds, Family Practice, Psychiatry, Pediatrics or Emergency Medicine) or other specialty (and familiar with Medicare patients) who is ready for a change? This is and outstanding opportunity for someone who is interested in working a Utilization Review role in the Camp Hill region. It is required you have a Pennsylvania license that is in good standing. It is a plus if you have....

- 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....

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