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POSITION SUMMARY: Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of....


Accountabilities and Responsibilities: - Engage and lead local IT team resources and business personnel to plan, implement, and support local as well as enterprise IT, laboratory, and business systems. - Be an integral member of multiple global IT and system teams, planning and implementing a global IT vision and infrastructure. - Exercise project management of local IT projects, including schedules, updates, meetings, documentation, resources, and completion milestones. - Proactively....


POSITION SUMMARY The Analytical Instrumentation Manager will be responsible for the management of daily activities in support of all analytical equipment in Quality Control. The manager will assure that activities associated with the testing, release and results reporting of materials, products and components meet established and expected quality, Data Integrity requirements, regulatory and customer requirements. The Manager will regularly interact with departments on site and at a corporate....

- Lexington, KY

Company Overview: This company has been a client of mine now for almost 3 years and I can definitively say that they are unique. From people I have placed here, to my own firsthand experience in visiting their facilities and talking with their people, they do things differently. They take care of their employees, they (truly) care about their customers and they are growing quickly. Their offices in Lexington KY (population 300,000+) are right off of the Bourbon Trail and are located in the


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


The Director, Clinical Pharmacology acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team. The Associate Director/Director, Clinical Pharmacology is responsible for clinical pharmacology programs for assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. The Associate Director, Clinical Pharmacology will work in close collaboration with different....


Reporting to the Vice President, Drug Development-Generics, the Director, Project Management will use the global PDP (Product Development Process), allied systems & tools, to plan and manage/coordinate resources and activities related to product development and maintenance of business projects throughout Global R&D, and other company organizations. Responsibilities: Responsibilities:Champion and lead projects for new generic product development.Management of project team members from....


POSITION OBJECTIVE: The Senior Manager, Clinical Supply will be responsible for end-to-end drug supply planning activities across the Client clinical portfolio and for leading the clinical drug supply team. Responsibilities include forecasting supply requirements across the clinical portfolio and managing IP (Investigational Product) production and distribution process on time, with good quality, in compliance with Health Authority regulations/guidelines and Client SOPs. Collaborates and....


POSITION OBJECTIVE: Responsible for leading the CMC (Chemistry, Manufacturing and Controls) regulatory function, the Senior Manager, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing....


POSITION OBJECTIVE: The Director of Clinical Pharmacology and Drug Metabolism and Pharmacokinetics (DMPK) is responsible for overseeing internal and external activities associated with understanding the absorption, distribution, metabolism and excretion properties of multiple drug candidates in preclinical and clinical development. The person will play an active role on cross-functional program teams, this includes planning development strategies and interpreting data, as well as making....


Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....


Executive Director, Clinical Operations The Executive Director of Clinical Operations is accountable for the overall operational strategic planning, oversight and delivery of clinical development programs. The Executive Director is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Executive Director will also lead key strategic Clinical Operations organizational initiatives and be a member of the....


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.Industry experience within pharmaceutical....

- Pasadena, CA

Clinical Data Coordinator A newer Biotech company with a growing, innovative, science driven team. As process owner, the Clinical Data Coordinator, manages in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. In addition, the position is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other....


This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....

- Any US State

Pharmaceutical company hiring MSLs- GI and Pain and Addiction There is three openings for an MSL in Pain and Addiction to cover the whole United States in the: East, Central and West. There is one openings for an MSL in GI for Texas region only please only apply if you have previous and recent Medical Science Liaison experience for the pharmaceutical or biotech or medical device industries looking for three or more years of experience as an MSL The Medical Science Liaison (MSL) plays a crucial


High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Global Pharmaceutical company is hiring an Executive Director to head up their Renal Medical Affairs Division this Executive role will report into the Executive Vice President of Medical Affairs and spear head the high profil department must be Nephrologist with at least 3 years of medical affairs experience Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical


Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....

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