Legal Assistant - White Collar and Securities The candidate will, under the general direction (both oral and written) of an attorney, use independent judgment and initiative to perform both routine and complex duties, with special emphasis in the litigation practice area. Will organize documents and maintain case files. Index documents and develop document organization/retrieval systems. Coordinate the creation of and maintain case management repositories such as eRoom. Gather documents and ...
Oversee and/or assist with a variety of Quality Assurance and/or Document Control functions. Ensures compliance with GMP regulations and internal policies and procedures. Maintain a teamwork approach to all tasks and nurtures professional relationships with other departments and outside agencies. Ensures accurate and timely processing of all Quality Records.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Independently manage complaint process:
o Perform evaluations of returned complaints and ...
Summary: The successful candidate for this position
will be someone with significant, specialized experience with global regulatory
requirements in the bio/pharma industry and a strong team orientation. This
Attorney will work with other Attorneys in the client’s Legal Department on
matters relating to regulatory requirements for investigational and approved
products, regulatory submissions, clinical trials, drug safety management,
labeling and label modification, as well as R&D and clinical ...
Legal Assistant - Trial Duties: Will work under the general direction (both oral and written) of an attorney uses independent judgment and initiative to perform both routine and complex duties, with special emphasis in the litigation practice area. Organize documents and maintain case files; index documents and develop document organization/retrieval systems. Coordinate the creation of and maintain case management repositories such as eRoom. Gather documents and information from client offices, third ...
• Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs/BLA's/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.
• Contact point for all regulatory interactions with the respective local Health Authorities. ...
Summary of Position
The Health Care Economics Senior Specialist (HCES) is responsible for developing, implementing, and managing global economic and statistical outcomes research plans for a defined portfolio of medical device products within the major Medical Device Global Business Units (i.e. Surgical Solutions, Vascular Therapies and Respiratory/Monitoring Solutions). The position also does analyses to support business development initiatives and programs across company. The HCES will assist in ...
Manager, Regulatory Affairs
Contract: 12 month renewable
Serves as a liaison between the company and regulatory agencies for all assigned projects and is responsible for day to day regulatory support. Expected to provide guidance within Regulatory Affairs and to data generating departments to ensure timely filing and approval/maintenance of assigned programs.
Duties and Responsibilities:
• Responsible for representing Regulatory on clinical trial working group ...
Associate Director, Regulatory Affairs
Contract: 12 months renewable
This individual is expected to provide leadership within the Regulatory Affairs Labeling group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative
on relevant project teams.
Duties and ...
7291 Director of Legal Affairs-Employment/Labor, Newton, MA
*Function as a litigation and employment law subject matter expert. Stay current with applicable U.S. federal and state legal and regulatory requirements. *Provide practical and sound legal advice and counsel to Human Resources and management on all legal issues concerning the employer/employee relationship,including but not limited to hiring, employee relations, performance management,
discrimination, harassment, wage and hour, non ...
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, ...
Please read the entire job description below and if you are qualified, send your most current resume in a Word document to: [email removed]
Manages all regulatory interactions with local health authorities in the US and Canada. Provides input into the development of regional RA strategies
- Central contact point for all regulatory interactions with the respective local Health Authorities
- Monitors local guidelines and vaccine specific recommendations
- Prepares and/or comments on draft ...
7291 Director of Legal Affairs-Employment/Labor, Newtown, MA
Function as a litigation and employment law subject matter expert. Stay current with applicable U.S. federal and state legal and regulatory requirements. Provide practical and sound legal advice and counsel to Human Resources and management on all legal issues concerning the employer/employee relationship, including but not limited to hiring,
Visit JDHUNTR.com for job details and the employer's name and contact information. Browse and ...
Seeking 5+ years experience in medical device regulatory affairs registering medical devices in USA, Canada, Europe, and Latin America and track record serving as Regulatory Affairs Manager or Director position requiring the mentoring, coaching, and leading of a team and interfacing with the FDA, giving presentations for conferences and influencing KOL's.
High growth visible position with top company. Salary $120,000 to $160,000 plus bonus plan; company paid full family coverage medical, dental, ...
Seeking 5+ years regulatory affairs experience with a diagnostics and-or medical device development and manufacturing company with a personal track record involving multiple successful submissions to the US, EU and Canadian regulatory agencies to:
*** Provide strategic support to currently marketed products including; review of design and process changes, labeling, promotional materials and documentation for compliance and for changes requiring regulatory agency approval and notification.
Seeking Experience in the medical device manufacturing industry with a specific focus on regulatory compliance in the FDA Class I and II medical devices and track record successfully preparing documentation for 510(k) regulatory submissions and gaining approvals.
*** Manage all Quality Assurance and Regulatory Affairs functions.
*** Develop and implement global regulatory and compliance strategies.
*** Instill a corporate culture of the development, maintenance and use of effective ...
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