Medical Advisor
2 weeks ago
As a Medical Advisor at AbbVie, you will provide leadership and oversight for assigned products and projects in collaboration with affiliate/Area Medical teams, Marketing, RA, Clinical, and other functional areas. Your expertise will be essential in establishing and approving scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports.
You will participate in the design and execution of clinical trial safety, product safety, and risk management plans. Additionally, you may be responsible for routine and ad hoc safety monitoring reports to regulatory agencies and reviewing, assessing, and reporting applicable Adverse Events (AEs) and Serious Adverse Events (SAEs).
As a key member of the Global Project Team, you will oversee the conduct of clinical trials and be medically and scientifically accountable for the resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring, and other scientific reports submitted to regulatory authorities.
You will also provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease-specific information. Your role will involve staying up-to-date with professional information and technology through conferences and/or medical literature and acting as a therapeutic area resource.
Responsibilities include understanding regulatory requirements related to clinical studies and global drug development and being accountable for complying with those requirements. You will serve as the scientific team interface for key regulatory discussions and may act as a medical/scientific leader for projects within an area or across several areas.
Key qualifications include a Medical Doctorate (M.D.) degree or equivalent, relevant therapeutic specialty experience in an academic or hospital environment, and a minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia. Proven leadership skills in a cross-functional global team environment are essential, as well as the ability to interact externally and internally to support global business strategy.
Able to run a clinical study or medical affairs team independently with little supervision, you will possess expert knowledge in a relevant therapeutic specialty and excellent oral and written English communication skills. For clusters of countries, multi-lingual skills are preferred.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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