alternative resources company Jobs

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Manager, International Regulatory Affairs

Alternative Resources Company - Somers, NY

The Manager, International Regulatory Affairs will report to the Director, Regulatory Affairs and, under the direction and guidance of the Director, will work to obtain market authorization for OTC drugs and medical devices outside the U.S. The Manager will also correspond with foreign regulatory authorities and the company’s international distributors as needed to ensure that all products dist...

Application Deadline: None

Senior Director, Supply Chain

Alternative Resources Company - Somers, NY

The Sr. Director, Supply Chain QA will establish and maintain the Disposition Quality System for company aligned with regulatory requirements and company Quality policies. He/she will provide quality oversight of company contractors to support the manufacturing, testing, release and distribution of clinical and commercial products and medical devices to approved jurisdictions. This includes ove...

Application Deadline: None

Director, Compliance and Audits

Alternative Resources Company - Somers, NY

The Director Compliance and Audits will establish and maintain the global Supplier Quality Management System for company aligned with regulatory requirements and Quality policies. He/she will ensure that all GXP suppliers are qualified and audited in compliance with company SOP’s. The incumbent will develop the external audit schedule and manage the program using internal and external auditors....

Application Deadline: None

CAPA MANAGER

Alternative Resources Company - Somers, NY

Will oversee the GMP process for the company Corrective and Preventive Action system. This role will drive this process for QA with emphasis on compliance to company SOPs and applicable Regulatory requirements. The CAPA Manager will interact with key stakeholders in the organization as well as third parties for the timely and accurate generation and approval of CAPAs and PAs. This role will lea...

Application Deadline: None

Associate Director, Product Complaints

Alternative Resources Company - Somers, NY

This role will oversee the processes for Product Complaints for Marketed Products and Clinical Trials and will oversee personnel for the administration of these systems. This role will drive these processes for QA with emphasis on compliance to SOPs and applicable Drug and Medical Device Regulations. The Associate Director, Product Complaints will interact with key stakeholders in the organizat...

Application Deadline: None

Analyst, Contracts and Pricing

Alternative Resources Company - Somers, NY

Analyst for the company’s sales pricing and contracts teams. Perform tasks that enhance sales productivity and opportunity, accounts payable functionality, and customer satisfaction.

Application Deadline: None

Assoc. Director\Director Regulatory Affairs Advertising & Promotion

Alternative Resources Company - Somers, NY

This position within the Regulatory Affairs department involves the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulation/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Will ensure that messages are translated into ad...

Application Deadline: None

Executive Director, CMC Regulatory Affairs

Alternative Resources Company - Somers, NY

Will supervise/lead/mentor regulatory CMC personnel so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition the position assists Industrial Operations Product Supply (IOPS) senior management in developing strategies/processes to meet corporate objectives.

Application Deadline: None

Assistant Director, Regulatory Medical Devices

Alternative Resources Company - Somers, NY

Responsible for providing input into the development, alignment, and implementation of technical regulatory strategies to ensure earliest submissions and first cycle approvals for assigned development projects on a global basis. The Incumbent will represent GRA on project development teams as it pertains to the technical regulatory aspects of the project. This includes, but is not limited to, e...

Application Deadline: None

Technical Writer (Batch Record Creation)

Alternative Resources Company - Somers, NY

Create, manage and oversee the generation of technical documents in support of Pharmaceutical Development, Operations, Technical Operations, Validation and Equipment Qualification activities for the Pharmaceutical Services Division of the company

Application Deadline: None

Principle\Manager Biostatistician

Alternative Resources Company - Somers, NY

The Manager assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as technical expert in a particular statistical area or application

Application Deadline: None

Associate Director, USPV Medical Records Team

Alternative Resources Company - Somers, NY

To oversee a team of Safety Data Specialists, and Safety Data Associates responsible for case receipt, triage and entry into the affiliate module of the safety database, duplicate check, follow-up, and reports for a specific TA or subset of TAs handling individual case safety reports and cases resulting from local literature searches. Accountable for initial determination of case seriousness, p...

Application Deadline: None

Manager Statistical Programmer

Alternative Resources Company - Somers, NY

A Manager provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using...

Application Deadline: None

Statistical Programmer I

Alternative Resources Company - Somers, NY

• A statistical programmer provides timely support to the study team on all programming matters according to the project strategies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The incumbent implements and executes the programming and project standards. Under general supervision assists in the d...

Application Deadline: None

Senior/Principal Biostatistician

Alternative Resources Company - Somers, NY

The position assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications is required. In some cases incumbent could serve as technical support i...

Application Deadline: None