Jobs at Alternative Resources Company

43 job openings

Save This Search

Refine Your Search

Show more Show less
Displaying results 1 - 15 of 43

Global Safety Leader MD –Hematology

Alternative Resources Company - Somers, NY

The Global Safety Leader MD provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for the hematology portfolio of products (both marketed and in development).The Global Safety Leader ensures patient safety of the company products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the ef...

Application Deadline: None

Global Safety Leader MD – Women’s Health

Alternative Resources Company - Somers, NY

The Global Safety Leader MD provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for the oncology portfolio of products (both marketed and in development).The Global Safety Leader ensures patient safety of the company products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effe...

Application Deadline: None

Global Safety Leader MD – Women’s Health

Alternative Resources Company - Somers, NY

The Global Safety Leader MD provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for the oncology portfolio of products (both marketed and in development).The Global Safety Leader ensures patient safety of the company products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effe...

Application Deadline: None

Global Safety Leader MD- Oncology

Alternative Resources Company - Somers, NY

The Global Safety Leader MD provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for the oncology portfolio of products (both marketed and in development).The Global Safety Leader ensures patient safety of the company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the ef...

Application Deadline: None

Director, Global Regulatory Affairs Strategy

Alternative Resources Company - Somers, NY

Oversee the development and implementation of new product regulatory strategy, considering the different legal status of the products, such as food supplements, food, cosmetics, medical devices or medicinal products, in the respective regions as applicable.

Application Deadline: None

Director, Commercial Regulatory Affairs (Ad/Promo)

Alternative Resources Company - Somers, NY

• The Director, Commercial Regulatory Affairs provides strategic input into the review and approval of effective yet FDA compliant commercial (advertising and promotion) campaigns and pre-commercialization activities. This person will serve as the regulatory lead and on at least two Copy Review Committees (CRCs) which they will Chair, and on the respective Product Medical Review Committees (PMR...

Application Deadline: None

Manager / Senior Manager, Regulatory Labeling

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

Senior Director, Global Regulatory Strategy

Alternative Resources Company - Somers, NY

Provide guidance and oversight to Global Regulatory Strategists with regard to the development and implementation of global regulatory strategies to ensure alignment to TA portfolio and that key regions are captured in the global regulatory strategy; develop Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (...

Application Deadline: None

Deputy Director, Global Medical Affairs Publications

Alternative Resources Company - Somers, NY

Contributes to the Global Publications Strategy, and develops and implements the Global Publications Plan for the company’s ophthalmology portfolio. Scientific publications represent one of the most important sources of reliable and credible information for practicing physicians and this role will ensure the presentation and publication of the clinical trial results in a manner compliant with t...

Application Deadline: None

Director, Medical Affairs-Hematology

Alternative Resources Company - Somers, NY

• Direct and participate in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved IND or NDA, post-marketing activities of currently approved and/or marketed products, and new clinical indications of existing drugs. Provide advice within the field of medical expertise and specialization to cross-func...

Application Deadline: None

Manager, Lean Site Champion

Alternative Resources Company - Somers, NY

Responsible for supporting change by leading, enabling and supporting the identification and quantification of continuous improvement opportunities where Lean methodology can be applied to successfully transform organizational culture and deliver business results. Drive waste reduction and increase productivity both Site wide and cross-functionally as an advocate for the external customer. Acti...

Application Deadline: None

Director, Regulatory Affairs

Alternative Resources Company - Somers, NY

1. Actively provide US regulatory strategy advice/direction for development and optimization projects • Major driver in the development and maintenance of the overall company US Regulatory strategy • Participate in compendia projects to update USP • Actively participate in Change Control Committee meetings at the site 2. US FDA Agent • administer the registration of facility/ies with the fe...

Application Deadline: None

Regulatory Document Operations Specialist

Alternative Resources Company - Somers, NY

• Responsible for formatting and publishing electronic documents for 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 (eg, FDA, EMA, ICH, etc). • Requires some guidance from direct manager. • Provides support and backup to management as needed.

Application Deadline: None

Pharmacovigilance Senior Case Evaluator

Alternative Resources Company - Somers, NY

• The PV Senior Case Evaluator (SCE) has the responsibility to perform a medical evaluation and an assessment of causality of adverse event /adverse drug reaction (AE/ADR) reports. Medical quality, consistency with company standards and timely evaluation of case reports must be reporting requirements and timelines. Expedited reporting of single case ADR reports to regulatory authorities largely...

Application Deadline: None

Associate Director Global Regulatory Affairs

Alternative Resources Company - Somers, NY

• Organizes and drives preparations for meetings and teleconferences with local Health Authority officials • Represents a region in close cooperation with the GRS who is the GPT member or may represents GRA on assigned GPT • May participate in Global Project Team and working groups • Develops the local regulatory project goals from development through life cycle. Contribute to global regulatory...

Application Deadline: None