alternative resources company Jobs

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Director, US Regulatory Affairs - Nutritionals/GI

Alternative Resources Company - Somers, NY

• Lead and manage US Category team resources and facilitate their development through individual development plans and performance assessment • Oversee development and implementation of new product regulatory strategies in the US, considering the different legal status of the products, resulting in timely product approvals in the US • Proactively identify regulatory issues/risks and design/exec...

Application Deadline: None

Associate Director - Director, Regulatory Affairs

Alternative Resources Company - Somers, NY

This position will function as the US Regulatory Affairs expert to develop and implement US Regulatory strategy. This individual will maintain and interpret updated knowledge of US guidelines, counsel and guide global colleagues and interact and negotiate directly with the Regulatory Agency.

Application Deadline: None

Senior Manager - Associate Director, Quality Assurance

Alternative Resources Company - Somers, NY

Responsible for implementation of quality system and overseeing all quality related functions within the facility. The primary function is to ensure compliance with all regulatory agency requirements, as well as internal quality system requirements. This includes – but is not limited to – quality system implementation and maintenance, documentation management, training, internal and external au...

Application Deadline: None

Manager / Sr. Manager, Biostatistics

Alternative Resources Company - Somers, NY

Provides leadership and guidance as the statistical expert on a project team, with minimal direction from Therapeutic Area lead biostatistician. Accountable for all statistical aspects of project studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. May have regional or global management responsibility. In some cases, incumbent could serve as ...

Application Deadline: None

Principal Statistical Programmer

Alternative Resources Company - Somers, NY

Provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The i...

Application Deadline: None

Director, Global Labeling

Alternative Resources Company - Somers, NY

The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs (GRA). This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. Reporting to the Head of Global Regulatory Op...

Application Deadline: None

Senior Manager, Data Analytics and Reporting-Corporate Compliance

Alternative Resources Company - Somers, NY

As compliance regulations continue to evolve both within the U.S. and on a global scale, industry leaders are looking at the future of utilizing data to not only collect and report, but to use this “Big Data” as an opportunity to assess and manage internal compliance programs. Through data mining and analytics, corporate compliance professionals can gain insight on compliance program effectiven...

Application Deadline: None

Associate Manager - Manager, Regulatory Labeling (2 Positions)

Alternative Resources Company - Somers, NY

Manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPl, and EU SmPc. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives

Application Deadline: None

Manager, Clinical Logistics

Alternative Resources Company - Somers, NY

The Manager, Clinical Logistics is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and company SOPs / WPDs. Contributes to ...

Application Deadline: None

Assistant Director - Quality GMP

Alternative Resources Company - Somers, NY

The Assistant Director – GMP Quality Assurance (QA) manages and coordinates GMP regulated QA activities from early stage development through commercial product. This individual is responsible for performing domestic and international audits/inspections ensuring compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards

Application Deadline: None

Manager – Quality GMP

Alternative Resources Company - Somers, NY

The Manager – Quality GMP is responsible for independently performing domestic and international inspections that ensure compliance to the FDA and other worldwide health authority cGMP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides suggestions for recommendations for corrective and preventative action to the Quality Senior Manag...

Application Deadline: None

Senior Manager - Quality Pharmacovigilance

Alternative Resources Company - Somers, NY

The Senior Manager – Quality Pharmacovigilance (PV) is responsible for performing domestic and international inspections that ensure compliance with the FDA and other worldwide health authority Drug Safety and PV regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides recommendations for corrective and preventative action and tracks corr...

Application Deadline: None

Senior Manager - Quality, GMP and Investigations

Alternative Resources Company - Somers, NY

Responsible for performing investigations related to product complaints and non-conforming events to ensure compliance to the FDA and other worldwide health authority CGMP regulations and guidelines, site SOPs, and industry standards. This individual provides recommendations for corrective and preventative action to the Quality Senior Management team. The Senior Manager – Quality, GMP & Investi...

Application Deadline: None

Associate Director, Medical Science Liaison – Dallas, TX

Alternative Resources Company - Somers, NY

Residing in the Medical Affairs Department and working with cross-functional teams, the MSL will apply scientific experience, knowledge, and skills to execute against strategic plans for emerging customers, including integrated delivery networks. Responsibilities include establishing and maintaining business relationships, advancing the company initiatives, presenting data, and eliciting insigh...

Application Deadline: None

Pricing Supervisor

Alternative Resources Company - Somers, NY

Responsible for the development, implementation and continuous review of a customer pricing guideline grid utilizing competitive market data and overall company profitability goals to ensure a competitive and profitable pricing strategy. Responsible for ensuring the proper pricing relationship exists between direct customer prices, indirect customer prices and indirect wholesaler source prices ...

Application Deadline: None