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

Sr. Clinical Programmer, Data Operations

Alternative Resources Company - Somers, NY

The Sr. Clinical Programmer, Data Operations is accountable for developing programs to create standard reports and listings for clinical data mgmt. and other areas of clinical for data review and data cleaning to conduct clinical trials in the Oncology Area. The incumbent will develop programs for patient profiles and ad-hoc reports for data review to support the clinical teams. The Sr. Clinica...

Application Deadline: None

Regulatory Submission Project Planning Associate

Alternative Resources Company - Somers, NY

Responsible for project management of Regulatory submission deliverables such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH).

Application Deadline: None

Regulatory Submission Operations Associate II

Alternative Resources Company - Somers, 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 (eg, FDA, EMA, ICH, etc).

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

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

Associate Director- Director, Regulatory Affairs

Alternative Resources Company - Somers, NY

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of company’s quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance i...

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

Supervisor, Contracts

Alternative Resources Company - Somers, NY

Responsible for core financial, pricing, rebate and contractual language review functions in support of the customer relationships including but not limited to customer contract compliance and profitability, ad hoc price challenges, annual pricing bids, customer contract agreement review and product target modeling. Responsible for creating the Business Analyses in order to review customer prod...

Application Deadline: None

Manager, Quality Assurance Audit

Alternative Resources Company - Somers, NY

A well known pharmaceutical company seeks a Quality Systems Auditor to audit the companies current and prospective suppliers of materials and services used in the manufacturing of drug products as well as the internal manufacturing systems for cGMP compliance.

Application Deadline: None

Director of Clinical Operations

Alternative Resources Company - Somers, NY

Director of Clinical Operations will lead the US Clinical Operations Team comprised of 14 staff members. As this is a regional leadership role, the qualified candidate will participate as a member of the clinical development leadership team, partnering with team colleagues, contributing to the overall strategic direction and vision of the clinical development function. The incumbent will be res...

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

Maintenance Planner/Scheduler

Alternative Resources Company - Somers, NY

This position will provide Computerized Maintenance Management System (CMMS) oversight using SAP PM (Plant Maintenance) functionality at an SME (subject matter expert) level of competence to plan and schedule maintenance and calibration work for all maintenance and calibration activities at the company. This role will include oversight of all Preventive Maintenance and Calibration documentation...

Application Deadline: None