(US-Texas-Austin) Client is a leader in the development of cardiac implantable devices, including prosthetic heart valves, and medical technology areas of business. They are in search of a Director of Research and Development who is responsible for the overall engineering, scientific activities, research and development planning, and project management. RESPONSIBILITIES: ·Responsible for implementation of scientific, engineering, and corporate-wide technical research policies and programs ·Administer highly technical engineering/ scientific programs and projects ·Advise appropriate personnel of the latest technical, scientific, and engineering developments ·Partnering with Manufacturing and Quality Control Departments when preparing production and process designs and establishing uniform specifications for materials and equipment ·Prepare and correlate short and long term scientific and engineering plans and programs for design, construction, or alteration of activities ·Establish and administer procedures pertaining to the discovery of new products, the alteration and improvement of existing products and to the control of the quality of these products ·Develop and implement strategies for earliest possible product approvals ·Propose budget requirements, manage departmental performance within approved budgets and timelines ·Supervision of records of formula, process methods, and product construction standards ·Assistance in obtaining patent protection ·Personnel training and development of individual growth plans REQUIREMENTS: ·Graduate degree in science, engineering or technical discipline ·10+ years experience in Medical Device Technology ·7+ years management experience with product development materials research, and/or applied research relating to the health care industry, preferably with Class III cardiovascular devices ·Knowledge of medical devices, preferably implantable cardiovascular products ·Understanding of regulations and quality standards applicable to medical devices ·Ability to work on complex problems where assessment of situations ·Superior collaborative and interpersonal skills ·Strong management and organizational skills Competitive salary + bonus + relocation assistance.
(US-Texas-Austin) Client is a leader in the development of cardiac implantable devices, including prosthetic heart valves, and medical technology areas of business. They are in search of a Director of Clinical Research who will be responsible for the overall management of the department. RESPONSIBILITIES: ·Monitoring of post market outcome studies ·Preparation of FDA regulated and patient registration activities ·Provide support on all clinical studies ·Directing and supervising statistical services ·Creation and enhancement of all team individual development plans ·Evaluation and monitoring of departmental budgets ·Clinical evaluation activities for regulated clinical trials ·Compliance of clinical investigations with FDA and regulatory agencies ·Management of Clinical Monitors ·Development and review of protocols and budgets for all clinical studies REQUIREMENTS: ·Bachelor’s Degree in Health Sciences ·10+ years direct experience ·5+ years clinical research experience with class III medical devices or other related medical/pharmaceutical company ·8+ years management experience Competitive salary + bonus + relocation assistance.
(US-Massachusetts) To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications. Ensure that data submitted in response to regulatory agency request or questions, challenges the agency (when appropriate), adequately addresses concerns and are submitted in a timely fashion, meeting highest quality standards. Lead and influence strategic efforts of members of Research and Development team to achieve product development goals in planning and submitting registration and approval of new imaging products. Job Responsibilities: - Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company's strategies. - Review and approve key segments of regulatory submissions. - Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. - Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. - Communicate to senior management regulatory strategic & tactical plans to achieve company goals. - Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas. - Work closely with R & D to develop an overall drug development strategy for all of the company's products. - Allocate resources and coordinate the activities of personnel to achieve the company's objectives. - Maintain an organization with high-level competencies and develop a success plan for the group to achieve the company's objectives. - Act as a recognized expert to work teams and other functional organization on complex problem resolution Interfaces: The VP Regulatory Affairs will report directly to the Executive Vice President with dotted line responsibility to the President of the Company. In that capacity, the VP Regulatory Affairs shall report on company regulatory affairs, FDA submissions, goals, strategies and tactics. In addition, he/she shall have responsibility for budget preparation as part of the overall corporate budgeting process and be responsible for overall management, expenditures and reporting for the division. 10 - 15 years of industry experience Attention to detail and follow through Medical/Pharmaceutical specified education 5 - 10 years of experience in dealing with the FDA Extensive communication skills Education: Advanced degree preferred, but not required.
(US-Massachusetts) Manage regulatory activities for the assigned product development project. Preparation and maintenance of the IND and NDA for pre- and post-marketed products, including tracking and assembly of new IND, NDA, IND amendments, NDA supplements, IND and NDA Annual Reports. Preparation and maintenance of the Canadian CTA as well as European applications. Plan, coordinate and prepare for the meetings with the regulatory authorities. Interact with the Regulatory Authorities as necessary. Review of clinical and nonclinical study protocols. Review of clinical and nonclinical study reports. Submission of safety reports for the investigational and marketed drug products and Annual Safety Reports for the marketed drug products. Ensure timely submission of Regulatory documents. Represent Regulatory at the Project Team Meetings. Work in a cross-functional team environment. Knowledge and understanding of: The drug development process, US regulations as well as the FDA and ICH published regulatory guidance documents, FDA structure, particularly CDER, IND, NDA Processes, structure and content of IND and NDA, various types of interactions with the FDA (formal meetings, submissions, etc.), various types of regulatory submissions including electronic submissions, Canadian and European regulations is a plus. An undergraduate or graduate degree in one of the life science discipline. 5 to 10 years experience in the pharmaceutical industry with 3-5 years experience in the area of regulatory affairs working directly with the regulatory authority such as the FDA. Fast paced office environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent computer skills. Good verbal and written communication skills.
(US-Washington) Responsibilities: Develop software and databases systems for protein bioinformatics and protein classification including: software design and implementation; data warehouse implementation; and development tools for data-mining and analysis. Required: Ph.D. in Computer Science or related fields; 2+ years experience in software engineering and software development. Languages: JAVA; C; C++; XML; PERL; and UNIX System. Preferred: Knowledge of databases; Oracle; general bioinformatics; and Unified Medical Language System (UMLS). Goals: Assist in the fundamental design and implementation of the next generation of the “Protein Information Resource” (PIR). This resource is a well known bioinformatics database that was the first ever protein knowledge -base and is now over 40 years old.
