Senior Manager Regulatory Affairs CMC – Ohio
Eagle Research - Ohio
Senior Manager Regulatory Affairs, CMC is responsible for the definition and implementation of CMC regulatory support to global products/ projects Support is provided through: Identifying, implementing, and managing CMC regulatory development strategies Preparing CMC filing docum...
Clinical Research Associate – New York
Eagle Research - New York City, NY
Overview: Support clinical study activities through study preparation and study site recruitment, initiation, performance, management, closeout, etc. Train project staff and study site investigators/coordinators and work with project teams to ensure successful clinical study comp...
Director Writing (Clinical and Regulatory) – New Jersey
Eagle Research - New Jersey
Responsible for managing and mentoring medical writing staff and external business consultants with a variety of writing responsibilities to achieve objectives and goals. Review writing assignments and daily activities of in-house and contract medical writers and train staff on d...
Senior Director, Risk Management & Safety Project Management – Mid-West Region
Eagle Research - Wayne, NJ
Develop and lead a broad range of communication to a global audience related to project and program information; Develop targeted global communication materials Provide support on global administrative issues and outputs Lead Risk Management Develop strategy, process and organiza...
Sr.Manager-Associate Director, Regulatory Affairs – New Jersey
Eagle Research - New Jersey
The position will contribute to the development of product registration strategies for efficient Worldwide and US registrations. Primary responsibility help with alignment of the registration plans with the commercial needs and to ensure regional strategies are consistent with th...
Manager, Regulatory Affairs – Labeling – New York
Eagle Research - New York City, NY
The Manager, Regulatory Affairs will be responsible for a variety of development projects, including all supporting regulatory activities required to prepare quality documents for submission to regulatory agencies to permit the legal distribution of pharmaceuticals for clinical o...
Senior Manager/Manager, Clinical Trial GCP Compliance – MASS
Eagle Research - Wayne, NJ
The Senior Manager will play a pivotal role in the development of the Clinical Trial Quality and Compliance function within the Clinical Operations department. The Senior Manager will assist with the development, implementation and maintenance of a proactive GCP compliance manage...
Director Project Management – New Jersey
Eagle Research - New Jersey
Actively leading internal cross-functional teams locally to ensure the effective delivery of project milestones Responsible for the management of COMBO product development through NDA approval and product launch Working closely with the Senior Vice President, clinical investigato...
Manager/Sr. Manager – Regulatory Affairs – New Jersey
Eagle Research - New Jersey
Assist in the review of pre-approval and post-approval submissions from internal team in accordance with current regulations from US FDA and Health Canada, as needed. Review includes a detailed scientific/regulatory review ensuring compliance to all appropriate regulations. Commu...
Associate Diretor Regulatory Affairs CMC – MASS
Eagle Research - Wayne, NJ
Position focus is on the development and post-approval of medical devices and combination products in sequence with drug delivery. Responsibilities include: Contribute to the development and implementation of CMC device regulatory strategy; Identify and assess regulatory risks Se...
Medical Director – Global Safety Officer – MASS or MN
Eagle Research - Wayne, NJ
This key position within the Quality function is responsible for providing medical and scientific expertise to bring high quality and efficiency to promote patient safety for products worldwide. This position provides critical input to the clinical trials for devices in the produ...
Senior Manager, Drug Safety – MASS
Eagle Research - Wayne, NJ
The Senior Manager, Drug Safety is responsible for managing a team of Safety Associates. This includes development and implementation of processes necessary for day-to-day operations, as well as the appropriate monitoring of the safety of the company's marketed products through p...
Auditor/Senior Auditor – New York
Eagle Research - New York City, NY
Assess quality systems, through audits and investigations of Contract Manufacturing Organization (CMOs), Contract Laboratories, raw material and component suppliers, clinical investigator sites, contract research organizations. Conduct on-site or paper audits and generates audit ...
Medical Director – Diabetes – New Jersey
Eagle Research - New Jersey
Provide endocrinology expertise to clinical trials in the drug and device development process Review and edit protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency Develop, plan and implement clinical research direction and visi...
Director, Drug Safety – New Jersey
Eagle Research - New Jersey
Responsible for providing drug safety management direction and vision in support of company objectives, goals and timelines Represent Drug Safety in development project teams and assume a key leadership role in providing clinical guidance for the drug safety area Key Responsibili...
Manager/Senior Manager, Drug Safety – MASS
Eagle Research - Wayne, NJ
Manage the daily activities of the clinical trial Safety and Benefit-Risk Management function Directly supervise Safety Associates in the collection, evaluation, and collation of both clinical trial and post-marketing adverse event reports. Qualifications Overview: Minimum of Bac...
Medical Director, Medical Affairs – New Jersey
Eagle Research - New Jersey
Represents the company and its therapeutic area products at internal and outside meetings Assists senior leadership with assessments and intelligence on potential new products and due diligence activities Provides overall scientific and medical oversight within the therapeutic ar...