Intercept Pharmaceuticals Manager/ Senior Manager- Medical Affairs Operations- Medical Research in New York, New York
The Manager/Sr. Manager, Medical Affairs Operations, Medical Research is responsible for supporting scientific and operational activities relating to the Investigator Initiated Research (IIR) and Collaborative/External Research Program as well as program management and operational support for the overall Medical Affairs Global research program. In addition, he/she will provide liaise with cross functional teams to ensure timely study initiation and tracking, proactively raising potential risks and opportunities to the research plan, and strategies to mitigate risks.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Manage the logistical activities of Medical Affairs Research, including IIR and Collaborative/External Research. This includes but is not limited to RFP processes, study contracting, initiation, tracking, document maintenance, vendor management and addressing investigator inquiries
Schedule and manage scientific review committee meetings (eg, observational protocol review meetings; IIR internal review and process meetings, external expert IIR review meetings, post hoc analysis prioritization meetings) and document relevant outcomes
Establish and maintain medical affairs IIR and Collaborative/External Research website(s)
Establish and maintain the Medical Research, including IIR and Collaborative/External Research database (superuser). Generate reports as necessary to support business needs.
Develop, maintain departmental SOPs, charters and policies and provide training to internal/external customers
Liaise with relevant departments including pharmacovigilance to ensure appropriate adverse event collection/reporting, product development to confirm proper labeling and timely compound supply for studies etc.
Other duties as assigned to support the medical affairs research department
A Bachelor’s or Master’s degree in a scientific discipline (Biology, Chemistry or related) or a Healthcare professional (RN, PharmD/BS-Pharmacy, PhD or other relevant degree),
Minimum 2-4 years of experience in the pharmaceutical or biotechnology industry required
Previous experience with Clinical Research, IIRs, HEOR, Epidemiology, and Medical Affairs preferred, especially with seasoned knowledge of project management and database systems
Understanding of IIR/grant processes and support activities for clinical, preclinical and non-interventional studies. This includes budget review, contracting and payments, and ensuring that all activities are consistent with requirements and guidelines of FDA, OIG, ACCME, AMA and PhRMA Code.
Solid understanding of the cross functional drug development processes (Clinical operations, Data Management, Biostats, and Regulatory)
Proficiency with standard desktop computing programs (e-mail, Word, Excel, Powerpoint) and relational databases
Excellent verbal and written communication skills, detail-oriented personality, and ability to work across functions
Must be self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work
Must be able to manage their own work, with ability to prioritize, plan and organize work assignments of the team while working under strict timelines
Keyword: Manager/ Senior Manager- Medical Affairs Operations- Medical Research
From: Intercept Pharmaceuticals