Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Associate Director Study Medical Expert
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Associate Director Study Medical Expert, are to:
Support the Global Clinical Development team;
Bring expertise on the indication studied;
Bring in depth knowledge about the study and its patients;
Help select the best countries to perform the trial;
Provide input into the project standards;
Support the writing of study-related publication;
Be the medical point of contact regarding the trial to outside bodies;
Defend the trial to regulators, IRBs;
Prepare for DSMBs, steering committee and external consultants;
Be able to answer and discuss in depth questions about the trial and its results;
Be the point of reference for the Country Medical contact person;
Provide consistent replies across the countries /regions regarding the trial both to IRBs and health authorities;
Help/ guide the country medical contact people in their study specific local tasks;
Keep updated medical FAQ lists for the study;
Be the source of expert knowledge in the therapeutic area/pathology;
Keep up to date with scientific progress/ literature in the area;
Support the participating countries in their needs of medical knowledge, e.g. through training/presentations to top KOLs etc.;
Participate in important local/regional/global advisory boards;
Help prepare/ negotiate Health Authority Approvals and reimbursement.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
M.D., D.O. or equivalent degree and Subspecialty postgraduate medical training;
Fluent in English, both written and spoken;
Familiar with the regulatory and legal environment;
Collaborative and team-oriented worker;
Sensitive to diverse global cultures;
Strong communicator for both scientific discussions and training.
Domestic relocation may be offered.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Location: United States : New Jersey : Whippany Division: Pharmaceuticals Reference Code: 117262 Contact Us + 1 888-473-1001, option #5
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