Associate Director Medical Affairs-Cardiovascular

Associate Director Medical Affairs-Cardiovascular

 

Be a part of one of the largest and fastest growing pharmaceutical companies in the world.  A top twenty global pharmaceutical company offering excellent career growth opportunities and the ability to influence the direction and outcome of critical projects.

 

Requirements include: 

·  Doctor of Medicine Degree

·  Minimum of 2 years experience in clinical research, preferably in the Pharmaceutical industry

·  Must have thorough medical/scientific knowledge in cardiovascular, analytical skills, knowledge of drug development and regulatory requirements

·  Good oral and written communication skills

·  Computer skills and ability to work as part of a team

 

Responsibilities include:

·  Responsible for conduct and/or management of clinical trials including protocol development, study conduct and reporting. Duties may also include assignment as Trial Clinical Monitor, Local Clinical Monitor or both for one or more trials.

·  Supervises appropriate clinical staff in execution of operational aspects of clinical trials/projects.

·  Responsible for interpretation and summarization of clinical data and for documenting such information in medical sections of regulatory documents

·  Provides medical judgment on safety sections. May also review labeling for marketed drugs, manuscripts, publication plans and press releases.

·  Responsible for assuring adherence to governmental regulations and guidelines and SOPs in preparation, conduct and reporting of clinical trials. Also responsible for interpreting such guidelines to direct reports and investigators.

·  Develops and maintains relationships internally with others involved in drug development process, and externally with investigators, consultants and contract research organizations. Interacts with marketing and other internal groups.