ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in the United States, United Kingdom, Canada, Australia, Germany, Sweden, Japan, and the Netherlands, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The primary role of the Operations Manager is to provide high quality medical information service while fostering strong client relations and client satisfaction. The Operations Manager will be expected to take responsibility for client projects, which could include projects being handled by other assigned Medical Information Leads (MIL) or Project Leads. The Operations Manager will have supervisory responsibilities for project(s) and may have direct or indirect management for assigned MIL or Medical Information Specialists (MIS). The SMIL will be expected to develop a deep level of expertise of the client system, process and products. Depending on the specific client, project and team situation, the Operations Manager may also be asked to take on other responsibilities including but not limited to client liaison/client management, program operations, quality assurance, training, escalation support, and medical writing.
Essential Functions Include:
Provides high quality medical information either directly in response to client requests or through support and mentoring of other staff involved in the delivery of medical information service. Requests may be received via phone, hard copy letter, email, fax or other channels.
Ensures responses utilize appropriate and approved sources such as labeling, standard responses, published literature, and other approved data as per ProPharma Group internal SOPs and client working practices/instructions.
Accurately identify, document, and report adverse events, product quality complaints, and other reportable information with high quality and within required timeframes. Support and mentor staff in successfully filling these obligations.
All work will be completed in accordance with regulatory requirements, industry standards, client and ProPharma Group internal policies and practices.
Supervisory tasks which include delegation of work, overseeing of MILs or MIS workload and project completion, payroll, and performance management.
Manages all aspects of new program setup and launch.
Engages as a fully functional member of the Medical Information team, ensuring all tasks are completed with high quality and on time.
Develops subject matter expertise in regard to assigned client systems, process and products.
Provides escalation support for ProPharma Group MIS.
Provides oversight of team to perform research, summarize data, and write custom responses on behalf of ProPharma Group clients.
Provides client support activities including participation in client meetings, when appropriate.
Provides training support as mentor and trainer for new hires and other team members.
Assists in supporting Quality Assurance functions.
May be required to provide guidance to dedicated team during after-hours coverage, if warranted. May be required to attend meetings outside of regular working hours.
Adheres to company and country specific privacy policies.
Necessary Skills and Abilities:
Ability to supervise others directly or as part of matrix and provide direction as necessary.
Ability to delegate workload and effectively communicate requirements to achieve successful completion of delegated tasks.
Ability to correctly identify inquirer's question(s) and formulate and communicate an accurate response utilizing multiple resources for information which may require scientific interpretation.
Excellent written and oral communication skills and computer literacy.
Working knowledge of medical terminology, pathophysiology, pharmacology, regulations, and industry standards.
Ability to search the published medical literature, evaluate published scientific information and create written responses that summarize such content.
Demonstrate planning, prioritizing and organizational skills showing an effective workload management system and meeting deadlines of both own tasks and tasks that have been delegated to assigned MILs and MIS
Excellent interpersonal skills including empathetic customer service skills.
Understand and demonstrate the importance of providing superior customer service to clients to support the business.
Able to take responsibility for work allocated (ensuring tasks are followed through to completion).
Accuracy and attention to detail; able to understand and follow processes.
Ability to anticipate issues, develop and offer solutions to minimize disruptions.
Ability to organize and prioritize in quickly changing environment within resource constraints.
Ability to learn, take instruction and apply to daily operations/tasks.
Receptive to constructive feedback.
Self-motivated. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
Effectively work independently and as part of a team.
Must be a licensed Pharmacist
Minimum: 5 years of experience as an industry (pharmaceutical or biotech company employee) or academic MIS; or other equivalent/closely-related experience. 3 years of medical information experience in support of drugs or biologics that treat rare diseases.
Preferred: 1 to 3 years of experience in a healthcare setting plus a minimum of 5 years' experience in an industry (pharmaceutical or biotech company employee) or academic MIS or other equivalent/closely-related experience.
Most Preferred: 5 to 7 years of experience in an industry (pharmaceutical or biotech company employee) or academic drug information setting, or other closely related experience in the pharmaceutical industry.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*
Propharma Group, Inc.