Medical Affairs Scientist Serbia
3 days left
- Experience Level
- Experienced (non-manager)
The Medical Affairs Scientist will partner with one or more Medical Directors to provide scientific input to clinical development programs, with an emphasis on ensuring scientific integrity of clinical trial data. The Medical Scientist will collaborate with Medical Directors and cross-functional team members on data reviews and may support other Medical Management activities for successful execution and conduct of clinical trials.
- Conducts regular and ad-hoc review of clinical data to identify risks and data patterns or trends under the supervision of the Medical Director(s), using one or more of the following tools: data listings, figures, tables, subject profiles, vendor data exports, coding listings, and visual analytics dashboards and reports.
- Identifies and issues scientific data queries; may oversee transcription of medical queries by support staff; may review responses to medical and scientific queries with the Medical Director(s) to authorize query closures.
- Interacts with internal team, customers and vendors in the areas of medical and scientific data review and eligibility review.
- Works with Medical Director(s) to develop requisite Project Plans for the Medical & Scientific Management Business Unit, and supports review of cross-functional Plans. May engage with customers to coordinate the acquisition of necessary medical/scientific input to prepare some Plans or activities (e.g., Advisory Committees or other medical committees).
- May partner with Medical Director(s) to identify scientific and clinical risks and mitigation strategies, and to perform protocol deviation review and trending.
- Collaborates with Medical Director(s) to prepare materials for various study meetings based on study scope, including but not limited to: Kick-Off Meetings, Investigator Meetings, and Medical Meetings.
- Collaborates with Medical Director(s) and Functional Lead(s) to manage activities related to Medical Committees, if in scope (e.g., Safety Review Committees Steering Committee meetings, etcetera).
- MSc Degree in life sciences, RN, PharmD, PhD, MD, or equivalent with relevant scientific experience and/or training discipline
- Must possess an understanding of scientific principles to assure effective and high quality scientific and medical data review
- Must have excellent time management techniques to handle multiple tasks and deadlines while delivering high quality work in a highly regulated and dynamic environment
- Must have ability to adapt to fluctuating timelines, work demands and changes in scope of work
- Ability to troubleshoot situations and demonstrate judgment to invoke leadership support when needed
- Must possess excellent written and oral communication skills, to include compilation and delivery of presentations to internal and external stakeholders
- Must demonstrate excellent technology skills including MS Office programs, spreadsheets, presentation tools, and use of databases
- Prior knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines preferred
- Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.