Johnson & Johnson companies are equal opportunity employers.
MANAGER MEDICAL AFFAIRS-4813130813
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Medical Affairs, located in Fremont, CA.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
Responsible for the operational oversight in medical affairs to achieve organizational objectives. Manages the design and implementation plans of medical affairs program, including identification of critical paths, budget development and tracking of all projects. Manages and delegates work of medical affairs team (internal and/or external). Participates in the clinical/medical education of internal teams. Manages budget, contract negotiation and oversight of all medical affairs vendor activities.
Responsible for the oversight of the Medical Information Center and associated vendors. Manages the creation of scientific product information support documents. Ensures that clinical information and data provided is accurate, fair-balanced, based on current medical literature, and provided to requestors within set timeframes. Ensures overall compliance and traceability of all responses related to medical information requests. Manages the inflow of all grant requests. Responsible for oversight of the Educational Grant review process and management of the Educational Grant budget.
Manages the publication planning process including assisting with preparation and review of all publication materials. Participates in the review of promotional material through the company copy clearance process. Implements policies and procedures for development and provision of medical and technical information pertaining to the company's products. Maintains collaborative working relationship between medical affairs and internal stakeholders. Acts as the liaison to various teams and represents Medical Affairs on other committees, such as those created for competitive marketing strategies, and to share/discuss scientific or therapeutic information issues. Participates in activities related to commercial/brand product support (e. g. competitive intelligence projects, business planning initiatives, medical conference data review).
Demonstrates project management and project planning skills, facilitation, negotiation, influencing, and leadership presence. Interaction with medical consultants and opinion leaders to effectively implement medical affairs strategy. Partners with Medical Monitor for the review and development of medical affairs materials. Provides upper management with updates and escalates issues as appropriate. Develops and lead Medical Affairs initiatives that lead to increased efficiency, quality and cost effectiveness for the entire department. Includes identification, initiation/planning, execution, communication, and ongoing evaluation
Responsible for hiring, training, development, management and performance evaluation of direct reports, if applicable. Demonstrates outstanding organizational skills and sound judgment. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for health, safety and environmental compliance.
Qualifications
Bachelors degree or higher and 7 or more years of related experience and/or training; or equivalent combination of education and experience. Experience and/or knowledge of the management of the medical affairs/clinical research processes for device or drug products is essential. Understanding of clinical trial design, statistics and regulatory processes (FDA/ICH-GCP), and project management is required. The candidate must have the ability to develop and maintain excellent working relationships with internal teams and external suppliers. Excellent written, oral, communication and organizational skills. Domestic or international travel may be required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
J2W:RAPS
J2W:ASQ
Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)
Job: Medical Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
MANAGER MEDICAL AFFAIRS-4813130813
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Medical Affairs, located in Fremont, CA.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
Responsible for the operational oversight in medical affairs to achieve organizational objectives. Manages the design and implementation plans of medical affairs program, including identification of critical paths, budget development and tracking of all projects. Manages and delegates work of medical affairs team (internal and/or external). Participates in the clinical/medical education of internal teams. Manages budget, contract negotiation and oversight of all medical affairs vendor activities.
Responsible for the oversight of the Medical Information Center and associated vendors. Manages the creation of scientific product information support documents. Ensures that clinical information and data provided is accurate, fair-balanced, based on current medical literature, and provided to requestors within set timeframes. Ensures overall compliance and traceability of all responses related to medical information requests. Manages the inflow of all grant requests. Responsible for oversight of the Educational Grant review process and management of the Educational Grant budget.
Manages the publication planning process including assisting with preparation and review of all publication materials. Participates in the review of promotional material through the company copy clearance process. Implements policies and procedures for development and provision of medical and technical information pertaining to the company's products. Maintains collaborative working relationship between medical affairs and internal stakeholders. Acts as the liaison to various teams and represents Medical Affairs on other committees, such as those created for competitive marketing strategies, and to share/discuss scientific or therapeutic information issues. Participates in activities related to commercial/brand product support (e. g. competitive intelligence projects, business planning initiatives, medical conference data review).
Demonstrates project management and project planning skills, facilitation, negotiation, influencing, and leadership presence. Interaction with medical consultants and opinion leaders to effectively implement medical affairs strategy. Partners with Medical Monitor for the review and development of medical affairs materials. Provides upper management with updates and escalates issues as appropriate. Develops and lead Medical Affairs initiatives that lead to increased efficiency, quality and cost effectiveness for the entire department. Includes identification, initiation/planning, execution, communication, and ongoing evaluation
Responsible for hiring, training, development, management and performance evaluation of direct reports, if applicable. Demonstrates outstanding organizational skills and sound judgment. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for health, safety and environmental compliance.
Qualifications
Bachelors degree or higher and 7 or more years of related experience and/or training; or equivalent combination of education and experience. Experience and/or knowledge of the management of the medical affairs/clinical research processes for device or drug products is essential. Understanding of clinical trial design, statistics and regulatory processes (FDA/ICH-GCP), and project management is required. The candidate must have the ability to develop and maintain excellent working relationships with internal teams and external suppliers. Excellent written, oral, communication and organizational skills. Domestic or international travel may be required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
J2W:RAPS
J2W:ASQ
Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)
Job: Medical Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.