32 Pharm./Biotech Job Openings Within 50 mi. of Ridgefield, CT

Displaying results 1 - 15 of 32
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Director, Regulatory Affairs - New Product Development

Alternative Resources Company - Somers, NY
Responsible for the New Product Development (NPD) Regulatory Affairs operations leading to effective new global drug submissions through approval for internally developed Generic products. This is to be accomplished by the development of, and adherence to, regulatory standards and practices across the global Regulatory Affairs organizations. Responsible to lead and direct a regulatory team to w...
Posted Apr 16, 2014   —   Application Deadline: None
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Specialist, Third Party QA

Alternative Resources Company - Somers, NY
Supports activities of the Quality Assurance Department in regards to third party manufacturers/packagers to ensure that the company remains in compliance with all relevant pharmaceutical regulatory requirements i.e. FDA GMP. Develops and/or supports objectives, strategies, systems and procedures for QA oversight of third party manufacturers with supervision of direct Management. Interfaces wit...
Posted Apr 16, 2014   —   Application Deadline: None
Green Key Resources

GMP Quality Specialist

Green Key Resources - Ardsley, NY
- Review batch records (commercial and clinical). - Review, assess and investigate product complaints. - Review and revise quality agreements. Qualifications - Must have prior GMP experience with auditing batch records, complaint handling and reviewing investigations/CAPAs. - Degree with 5+ years of industry experience.
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Data Manager

Green Key Resources - Ardsley, NY
* Responsible for overseeing data management tasks from study start-up through database lock, for clinical trials. * Collaborates with the Clinical Project Managers (CPMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard oper...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Regulatory Archive Specialist

Green Key Resources - Tarrytown, NY
- Maintains all electronic and paper archives for all Regulatory submissions, submission documents, and any related correspondence for multiple Regulatory Applications (INDs, BLAs, etc.). - Maintains Regulatory application indexes and lists using the Regulatory Application management tool. - Assists with reviewing and developing departmental procedural documents in accorda...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Regulatory Submissions Associate

Green Key Resources - Tarrytown, NY
- Responsible for building Regulatory submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications. - Requires guidance from direct manager. - Provides support and backup to management as needed. - Performs submission build activities, in...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

QC Associate

Green Key Resources - Tarrytown, NY
- Review notebook documentation, raw data and other documentation at an extremely detailed level for accuracy, consistency and completeness. - Ensures sample data are documented in a manner that is compliant with GLPs, protocols and SOPs. - Reviews all data, study reports, assay validation reports and other documentation in a timely manner to meet project timelines. - Identif...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Regulatory Labeling Associate Manager

Green Key Resources - Tarrytown, NY
- Ability to lead Cross Functional Labeling Team (CFLT) to address labeling issues, develop plans of action, and oversee completion of labeling project. - Ability to assimilate clinical and scientific information, and present it in a concise manner. - Ability to assess situation with regard to appropriateness of working independently versus seeking guidance from supervisor...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Senior Specialist - Pharmacovigilance

Green Key Resources - Tarrytown, NY
- Serves as liaison for internal and external personnel for safety-related issues, generally supports Phase III IV programs and/or LP. - Works closely with Regulatory, Clinical Development, Data Management, Medical Affairs and Commercial personnel. - Exercises independent judgment in processing cases and maintaining compliance with SOPs and applicable worldwide regulations...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Manager, Data Management

Green Key Resources - White Plains, NY
* Provides oversight of lead Data Manager(s) * Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. * Assists in the development of SOPs, Working Practice, Data Management Manual, and other data management standards. Qualifications * BS Mathematics, Scie...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Regulatory Document Specialist

Green Key Resources - Tarrytown, NY
- Ensures timely review of submission documents for proper formatting as well as publishes these documents, ensuring submission readiness. - Assists with developing and maintaining document formatting and publishing procedures and standards for regulatory submissions. - Assists with training staff on procedures and standards. - Becomes familiar with and assists in providing g...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Senior Data Manager

Green Key Resources - Ardsley, NY
- Participates in study planning and execution by contributing to the following activities in collaboration with Biostatistics and Clinical Operations: protocol review; case report form (CRF) design; CRF completion guidelines preparation; data management plan (DMP) development; database coding, transfer and edit check specifications review; user access testing (UAT) of electronic da...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Assistant Manager - Animal Care Facility

Green Key Resources - Ardsley, NY
- Maintains compliance with all client policies, procedures, and applicable laws and regulations including New York State Department of Health and the United States Department of Agriculture (USDA) as well as potential accrediting agencies. - Ensures compliance with drug enforcement regulations and guidelines. - Assists with the management of the daily operations of the animal fac...
Posted Apr 15, 2014   —   Application Deadline: None
Green Key Resources

Documentation Specialist

Green Key Resources - Danbury, CT
- Under general supervision, perform daily activities according to approved procedures and/or training such as hardcopy document scanning to pdf format, tracking of document status, maintaining hardcopy signatures, formatting hardcopy files with cover sheet, filing of hardcopy documents, etc. - Under general supervision, execute tasks associated with electronic documentation us...
Posted Apr 15, 2014   —   Application Deadline: None
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Vice President, Technical Operations

Alternative Resources Company - Somers, NY
Responsible for the overall leadership and execution of the Technical Operations strategies for Solid Dose and Liquid dose products for global markets at the three GTA Sites. The individual will lead the process development, launch, and validation of new products and continuous improvement and maintenance of the large commercial portfolio. Responsible to create and foster a dynamic and performa...
Posted Mar 31, 2014   —   Application Deadline: None
Displaying results 1 - 15 of 32