In search of a physician career change opportunity or a new non-clinical career? An executive search firm is looking to fill a Director, Medical Affairs position at a device company in New Jersey.
This is a management position with direct responsibility for managing the company’s developmental portfolio as it relates to clinical product development and registration. This position requires the ability to pro-actively direct the clinical and regulatory activities using a network of Contract Research Organizations (CROs) to further the ultimate product registration process for the company’s cardiovascular combination (Medicinal) products. The position is responsible for managing assigned clinical and regulatory activities, including ensuring company products meet regulatory requirements, directing timely preparation of organized, scientifically valid regulatory filings and communicating with regulatory authorities. The position is also responsible for developing and implementing clinical strategies for new and modified products, determining when technical changes are reported to regulatory authorities, and managing the vigilance reporting system. While this position will not be responsible for product manufacturing or testing, it requires the ability to communicate clinical and market requirements to the development team. Finally, as this position will have Management standing, there will be specific responsibilities for managing clinical and regulatory budgets.
DUTIES AND RESPONSIBILITIES:
A. REGULATORY AFFAIRS
1. Manage preparation and compilation of regulatory filings, including Investigational Device Exemptions, Clinical Trial Authorization requests to Competent Authorities, as well as related amendments, supplements, annual reports, etc.
==> Specific knowledge of clinical trial requirements for drugs;
==> Capable of managing multiple projects.
Act as a liaison between the company and the Registration Agencies, Competent Authorities, Notified Bodies, or other regulatory bodies responsible for registrations and marketing applications.
Develop and implement regulatory strategies for new and modified products.
Review and approve change control documentation, and determine submission and reporting requirements for changes.
Harmonize the presentation of information, data, and analyses to facilitate the use of such information in product registration dossiers and marketing applications worldwide.
Provide regulatory advice and guidance to product/project teams and other functional groups.
Participate in design control activities, including attendance at multi-functional meetings, determining regulatory pathways, reviewing and approving design control documentation, participating in design reviews, and other assistance as requested by the project team leader.
Review and approve product labeling and promotional materials to ensure compliance with regulatory submissions and applicable laws and regulations.
CLINICAL DEVELOPMENT
Identify and recommend the selection of clinical investigators to the management team; manage the relationship with clinical investigators once selected.
Ensure the timely management of clinical trials to include the coordination of CRO activities and serve as a clinical monitor, as needed.
Review and approve regulatory documentation necessary to ship clinical materials to investigational sites.
Serve as an expert on clinical requirements and communicate those requirements to the company in a timely manner.
Education Requirements: MD or PhD. RAC or other applicable accreditation a plus
Experience: A minimum of six years experience within the regulated industry (Medical Device and/or Pharmaceutical); experience with orthopedic products a plus. Working knowledge of clinical development processes with particularly attention to the laws, regulations, guidance documents, and clinical practices for Medicinals. Knowledge of medical devices and quality systems requirements a plus. Effective communication skills essential.
If you are interested in this position, please email your CV and a cover letter to info at PRNResource.com, and we will forward it to the executive search firm looking to fill this position.
S.A. 3-20-08
