This CRA will be primarily responsible for ensuring site compliance with specified research protocols and the accuracy of submitted data. The CRA will also be responsible for maintaining proper written documentation for the study records of all site interactions.
Presentation and training of clinical investigation plans (CIP) to site personnel, including investigators.
Coordinating IRB submission preparation and negotiating contacts with new clinical sites
Director of Medical and Scientific Affairs, North America.
The Director is responsible for establishing (COMPANY) as the technology leader in Point Of Care diagnostic products (e.g. whole blood biosensors for glucose, ketones, creatinine, and lactate on handheld beside analyzers and critical care analyzers) that will be used in clinical laboratories, critical care, radiology, and nephrology specialties. Key responsibilities include: build the North American professional network of Key Opinion ...
My name is Ashley and I represent The Fountain Group. We are a national staffing firm and we have an opening for a Senior Regulatory Affairs Publisher. This contract position will be located in Lexington, MA and expected to be a 6+ month contract. Please see below for position details.
Manages and prioritizes the tracking, compilation, and quality-checking of submission component documents; publishes and reviews regulatory submissions and correspondence
Ensures compliance ...
Pharmalink Consulting is recruiting for a Regulatory Submission Manager who will coordinate all aspects of CMC regulatory submissions relevant to their assigned projects and serve as the regulatory CMC representative on matrix teams, as appropriate.
Duties and Responsibilities:
Monitor changes to development plans and work with supervisor to design globally compliant CMC regulatory strategy for development products with supervision.
Drive global CMC regulatory submission activities (IND, CTA, ...
Our client is looking for a project manager with IT regulatory experience in the biotech industry. The position is located in cambridge, MA.
Project Manager – Regulatory IT
The INSIGHT Project Manager is responsible for the planning and execution of business process improvement and regulatory information management project. The INSIGHT Project Manager will work with business process owners, information technology staff, and subject matter experts to lead business process ...
Our client is looking for a contracts manager in Weston, MA.
This role will oversee the GMA-Hemophilia group responsible for setting up a Contracts Management database, liaise with Finance and Legal groups to ensure financial and reporting obligations are achieved for each agreement; monitoring and tracking all contract obligations, including event alerts to ensure event completion.
-Must have strong understanding of Contracts and Outsourcing, including understanding of legal, ...
Director of Regulatory Affairs-Med-Device
Boston - MA
The Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the regulatory functions. This position reports directly to the Sr. VP – Global Product Operations. This person manages Regulatory Affairs staff in addition to oversight responsibility for Regulatory consultants. This position coordinates departmental planning, manages multiple project teams and ...
Director of Regulatory Affairs
Location: Boston, MA
The Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the regulatory functions. This position reports directly to the Sr. VP – Global Product Operations. This person manages Regulatory Affairs staff in addition to oversight responsibility for Regulatory consultants. This position coordinates departmental planning, manages multiple ...
Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs BLAs/Post Marketing submissions, etc.)
Prepares and reviews local labels.
In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada.
Provides input into the development of regional RA strategies.
Monitors local guidelines and vaccine specific recommendations.
Prepares and/or comments on ...
Growing company seeks seasoned leader for GMP regulated Asceptic manufacturer. Director will strategize and execute all facets of manufacturing projects, which include cell culture, protein purification, and ready for distribution sterile packaging
** Develop capital budget and project costing; ensure that manufacturing activities are completed within budget and resource constraints.
** Direct scheduling, production set-up and clean up, following GMP regulations
** Ensure Continuous Quality ...
Seeking Senior level leadership experience. GMP regulated clinical and commercial manufacturer of Vaccine Grade Biologic products. Will be responsible for all facets of planning and execution of manufacturing operations.
** Ability to develop strategies for efficient and high quality production of antibodies, antigens, proteins and similar Biologics
** Thorough knowledge of GMP regulations
** Budget and resource management
** Experience with aseptic manufacturing and ...
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