As part of Medical Affairs and reporting to the Sr. Director, Medical Affairs, this individual would work with Medical, Commercial and Regulatory team members in planning, implementing and executing projects related to the development and management of a commercially-ready risk management program, in accordance with company SOPs, FDA and ICH guidelines and regulations. This individual provides internal accountability for the company’s REMS program and day-to-day management of the key risk management vendors.
This individual will play a pivotal role in managing timelines and deliverables for key risk management milestones for the company. He/she will need to apply project management related support to teams and team leaders to meet overall corporate objectives in building a compliant REMS program. This individual must work collaboratively with all levels of internal and field staff in addition to maintaining professional demeanor with outside contacts.
ESSENTIAL FUNCTIONS AND REPONSIBILITIES:
• Responsible for managing overall project timelines and deliverables for assigned projects.
• Responsible for the management of REMS database, certifications, fulfillment requirements, and reporting timelines.
• Serves as the REMS point person for the AcelRx Contact Center, Medical Science Liaisons, Commercial field staff, Wholesalers and Authorized Hospital Representatives.
• Joint responsibility for management of external vendors.
• Is accountable for routine and Ad Hoc reports to the senior leadership team as to the status and, when necessary, corrective action necessary to meet project timeline and deliverable objectives.
• Designs, implements and assesses the effectiveness of standardized project management processes and procedures. This includes standardized project tracking and reporting procedures..
• BS or higher Biological/Medical discipline or comparable field of study from an accredited college or university
• This candidate will have a minimum of 5 years relevant project management experience in medical device or drug delivery, which routinely required influencing in a multidisciplinary environment.
• Experience with and working knowledge of the risk management, REMS and related regulatory process are essential.
• Experience managing and leading the successful implementation of complex projects with multiple internal and external stakeholders.
• Excellent verbal and written communication skills with the ability to interface effectively with senior management, interdisciplinary project teams and external vendors. Experience leading cross-functional project teams is required.
Superior computer skills required. Must be experienced with word processing, spreadsheet and database applications, including MS Project and MS Office (Word, Excel, PowerPoint, Outlook), used to support REMS administration and management.