Most Recent Alternative Resources Company Job Listings

POSITION TITLE: Senior Regulatory Affairs Associate, Labeling JOB SUMMARY: Preparation and maintenance of the Master Artwork for Labeling to include Outsert/Insert, Container Label, Carton, Patient Information Leaflet, Medication Guide to support regulatory products development and marketing. Secure the cooperation of other team members; meet aggressive deadlines to ensure that regulatory age...

Position Summary: Assists Clinical Operations and Project Management as assigned in the administration, scheduling and coordination of project activities, including corresponding with team members globally, assisting with updating and review of tracking systems for project documentation, budgeting and contracts, archiving and information retrieval, and supporting the financial reporting of stud...

Validation Specialist (Cleaning Validation) Job Purpose: Responsible for ensuring compliance to the regulatory requirements of the cleaning validation processes and activities performed in the facility. Drives improvements of the cleaning validation process and performs a variety of routine and non-routine task related to cleaning validation, as managing and overlooking projects and changes, p...

SENIOR DIRECTOR TO VP, HEAD OF REGULATORY AFFAIRS Responsibilities: Carry out managerial responsibilities in accordance with the organization's policies, procedures and state, federal and local laws Plan, direct, coordinate and prioritize strategic activities of the Regulatory Affairs Department and assigned staff. Establish group goals and objectives in line with department goals and assure ...

The Packaging Engineer serves as the expert on packaging materials and the relation of the materials to the packaging process. The Engineer will support all packaging engineering activities for all marketed and new product packages related to serialization.

Description This position performs triage, data entry and follow-up on product complaints received by Company. This position monitors the quality of data entered in to the Product Monitoring databases and reconciles the data entered. In reconciling data, this position acts as a resource for answers to operational questions related to case processing and department procedures. The primary respon...

Title: Specialist - Sr. Specialist – Manager, Regulatory Operations Department: Regulatory Affairs POSITION OVERVIEW: The Specialist/Sr. Specialist/Manager Regulatory Operations is the Regulatory Department representative for assigned project(s) (i.e., INDs, IND amendments, annual reports, FDA meeting packages, NDAs, NDA amendments, etc.) He/she functions as a Project Manager, working in coll...

Packaging Engineer Job Purpose Provides packaging engineering support for all marketed and new product packages.

Auditor-Senior Auditor, Quality Systems A well known pharmaceutical company in New Jersey 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.

Position Summary: This position will have direct writing responsibilities of key documents, with a particular emphasis on clinical development related documents (i.e. - Company) protocols, study reports, abstracts/papers, investigator brochures, meeting and briefing packages, clinical summaries and overviews) but potentially across any or all departments as prioritized by the CMO, and will als...

Essential Job Function: Perform formulation development activities (including processing of small scale batches) under the direction of formulation project leaders. Perform physical and chemical characterization of raw materials and dosage forms. Maintain project and laboratory records. Work on projects ranging from formulation development for early phase clinical studies (bench scale) through ...

Sr. Process Validation Specialist / Engineer- The Senior Validation Specialist is responsible for planning, scheduling, execution and leading validation project assignments. Validation assignments include design, development, validation, qualification, and implementation of new and existing processes. Leads cross-functional project teams in the development and implementation of the validation...

Job Title: Manager Formulations Supervisor's Title: Director Formulations Primary Job Purpose: Provide technical leadership in Formulations to enable the formulation and product development, scale up and manufacturing process optimization in support of ANDA and NDA submissions. Implement systems necessary for product development in a regulated environment.

Associate Director – Global Regulatory Affairs This position will provide strategic direction to the development of new products in support of Consumer Healthcare Products and Generic Prescription Drugs.

Job Title: Senior Developer, ERP Systems Summary: This position will be responsible for software development, integration and technical support of ERP JDEdwards based solutions in the enterprise. It will require in-depth, hands-on understanding of JDE Applications, Tools and Technology offerings as well as Third Party tools necessary to support ERP operations. Solid knowledge of JDE appli...