Associate Medical Director - Safety Surveillance

Biotechnology and Pharmaceutical Associate Medical Director - Safety Surveillance Job Description:Associate Medical Director – Safety Surveillance – Marlborough, MADelivering on the promise of medical innovation begins at Boston Scientific! By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.General Summary:This key position within the Clinical function is responsible for providing medical and scientific expertise to bring high quality and efficiency to the clinical trial development process for devices in the product pipeline. This position may also be responsible for providing safety surveillance and analysis of post-market trial and product complaint data to help BSC manage and mitigate risk. This leader also may be responsible for the supervision and management of other safety professionals.Duties and Responsibilities:? Maintains timelines by providing high level medical/therapeutic guidance to internal and external customers including project teams, functional units, investigators, and regulatory agencies. ? Provides early, hands-on operational support to teams in clinical trial planning, protocol development, training of internal and external personnel, medical monitoring for trial safety, and quality control. ? Assists in implementation of worldwide practices, policies, and processes for the medical and clinical affairs function of the cardiovascular platforms. ? Provides therapeutic area expertise to support development and execution of clinical trials in device development process, as well as potentially support safety surveillance of post-market trials in partnership with the Medical Affairs organization. ? Reviews and edits protocols to insure accuracy, consistency with standard of care, logistical ease, and internal consistency at BSC. ? Reviews, edits and approves adverse event narratives to ensure that written summaries are medically accurate? Develops policies for interaction with independent study committees; ensures exchange of information with these committees is adequate to meet study timelines.? Provides direct physician support to Quality Assurance group for review of product complaints, MDR reporting criteria, health risk assessments, and product performance criteria. ? Writes and edits clinical reports for regulatory submission and updates to insure medical accuracy. ? Provides medical monitoring to insure patient safety and adequate reporting and coding of adverse events in clinical trials.? Will supervise or mentor safety personnel, including other managers and provide the appropriate guidance, coaching and development.Minimum Education & Experience:Medical degree required with board certification in area of therapeutic expertise. 3+ years of clinical experience with patient care. 3-5 years of clinical trial experience is desired. Some direct industry experience (device, pharmaceutical, and biotechnology) is desirable as well as previous experience managing staff. Working Conditions: General office environment, and includes approximately 40% to travel to research laboratories, meetings, and/or other BSC facilities. There is potential for exposure to blood borne pathogens and other potentially infectious materials.Competency Expectations:? Evidence of a management style characterized by leadership, vision, collegiality, teamwork, preparation and communication. ? Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions. ? Excellent coaching and mentoring skills ? Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect. ? Experience in writing scientific reports.? Strong organizational and interpersonal skills, including the ability to teach and coach others.? A self-confident, analytic, intelligent, strategic thinker with the highest personal integrity. Support of Quality Systems:Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.Boston Scientific (NYSE:Job Experience:*Minimum Education Required: Post DoctoralYears of Experience Required: At Least 3 YearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.