alternative resources company Jobs

18 job openings

Save This Search

Refine Your Search

Show more Show less
Displaying results 1 - 15 of 18

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

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 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

Quality Assurance Specialist - Pharmacovigilance/Risk Management

Alternative Resources Company - Somers, NY

Support overall quality of all Pharmacovigilance & Risk Management deliverables (aggregate documents and ICSRs) prepared for submission to regulatory authorities and/or license partners. Support adherence to and compliance with worldwide regulatory obligations as well as company SOPs, policies, procedures and contractual agreements. Assist with audits and inspection related activities.

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

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

Lead, Technical Process Operations

Alternative Resources Company - Somers, NY

• This position carries the responsibility for the direct client interface during the development, scale-up, transfer, and /or commercialization of products. This includes batch record creation, review, generation of DOE and sampling protocols, validation documents, authorship of final reports and technical project guidance to the client. • Expertise in fluid bed processing is highly sought, a...

Application Deadline: None

Senior Manager - Associate Director Regulatory Affairs

Alternative Resources Company - Somers, NY

• Maintenance of Drug Establishment Registrations (DER) covering all sites • Drug Listing, Create NDC numbers • Provide information on GDUFA requirements and GDUFA fees • Major driver of, develop and maintain the overall company US Regulatory strategy • Assist in the development and communication of and facilitate proper implementation of regulatory strategies on product specific issues • Fol...

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

Executive Director, Clinical Development

Alternative Resources Company - Somers, NY

Reporting to the VP Clinical Development, the Exec. Director, Clinical Development, will be responsible for leading the global clinical product development, managing the clinical program as medical lead and providing ongoing clinical perspective to the research and development strategy for the company pipeline, from start or acquisition of compound to regulatory approval and other therapeutic a...

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

Associate Director Intake Position

Alternative Resources Company - Somers, NY

• May be point of contact for health authority inspections and audits with regards to certain operational policies and procedures. • Attend meetings, conferences and forums in order to keep current with industry trends on systems and technology and using this knowledge to influence decision making and enhancements to the company’s pharmacovigilance systems and processes. • Serve as the point of...

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

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