PPD Senior Medical Director, PVG in Morrisville, North Carolina
Medical management of SAEs and medical oversight of clinical trials to ensure company SOPs, sponsor directives, and regulatory requirements are followed. Performs medical review of clinical study reports, attending and presenting at investigator and sponsor meetings, providing medical consultation to sponsors and project team members for clinical trial activities including timeframe business development through marketing application. May have responsibility for direct staff management for assigned physicians in the PVG department.
Education and Experience:
MD or equivalent
3 years of pharmaceutical industry experience
2 years medical affairs/pharmacovigilance/ SAE review experience
Or equivalent combination of knowledge, skills and abilities to perform the essential job functions
Knowledge, Skills and Abilities:
Mastery of basic medical management tasks such as SAE review, lab review, protocol inquiries and listing review
Ability to effectively mentor others
Strong medical knowledge and analytical skills
Excellent oral and written communication skills
Excellent interpersonal and team building skills
Excellent negotiating skills
Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem solve
Ability to exercise creativity and judgment
Expert knowledge of regulatory guidelines for adverse event reporting for serious/unexpected events
Expert knowledge of Federal Guidelines and GCPs, including ICH/regional regulatory safety reporting requirements
Familiar with guidelines for IND and NDA submissions and international guidelines for conduct of clinical studies
Working knowledge of biostatistics, data management, and clinical operations' procedures
Expert knowledge of the drug development process
Ability to effectively manage resources and budgets
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Travel requirements on average 25%
Long, varied hours required frequently
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
*Organization: Medical Org-United States (MDAUS)
*Title: Senior Medical Director, PVG
*Location: North Carolina-Morrisville - 3900 Paramount
*Requisition ID: 142896
*Other Locations: North America-United States-North Carolina-Wilmington