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Shanghai, , China
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .
Job Description
In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports.
Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. NB: All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials,
or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps a breast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
May act as medical/scientific leader for projects within an area or across several area. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
May lead cross functional sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations)
Initiate research projects and drive them to completion, resulting in high quality publications. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
Qualifications
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred. Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a clinical study or medical affairs team independently with little supervision.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
Expert knowledge in a relevant therapeutic specialty.
Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
For clusters of countries multi-lingual skills of language is preferred.
Additional Information
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. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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AbbVie
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Senior Medical Advisor
Solid sender is American slang for an exciting musician.
Officers, especially senior officers.
awesome; neat...That car is radical! (Rad for short)
Sender is American slang for a person who arouses others emotionally.
[medical nickname] amyl nitrite ampules
See You At The Senior Center
Sexual promiscuity; sleeping around. [I am no longer with Peter, he would not stop playing musical beds.].
The Senior Navy Chief Petty Officer.
Junior sailors who are employed by the senior members to spread rumours.
cool,awesome,sweet. "that was RADICAL man."
(Med-cap) Medical Civil Action Program. Pg. 515
Female senior citizens who sell OxyContin
Senior Moment
Spam medal is military slang for a medal awarded to all members of a force.
Senior Canadian Officer Present Afloat.
Radical is slang for very good; excellent.
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