Reporting Structure

Reports To:

Chief Medical Officer & Vice President, Clinical Development

Direct Report(s):

Medical Affairs Operations Specialists, Medical Information and Medical Communications

Areas Managed:

Medical Information

Overview

This position will play an integral part in evolving and growing the needs of the Medical Affairs team and work collaboratively across the organization, partnering to lead and drive successful execution of Medical Information and Pharmacovigilance functions and supporting the development of Medical Communications and HEOR.  Additionally, this role will support Medical Affairs Operations that span all franchises.

·       Direct the Medical Information function, including overseeing the Medical Information Call Center and innovating Medical Information content to respond to medical inquiries.

·       Provide operational guidance to the Associate Director of Pharmacovigilance to ensure successful implementation of Pharmacovigilance processes, systems, and training.

·       Foster relationships with US medical affairs Medical Directors to assess program needs.

·       In collaboration with Medical Directors, ensure systems, processes, and enabling technology are in place to support MSL team execution and identify areas for innovative resource improvement to enhance scientific engagement.

·       Support the execution of congress planning activities to help shape implementation of effective medical information congress presence and materials.

·       Serve as the point of contact with Global Medical Affairs, Global Medical Information, and Global Pharmacovigilance to ensure tactical alignment.

·       Work across matrix teams to collaborate in the development of strategies for Commercial, Market Access, Business Development, Clinical Development, Legal/Compliance, Quality, Regulatory, and Finance.

·       Serve as the business owner for key Medical Affairs systems, including Veeva MedComms.

·       Develop Key Performance Indicators for medical affairs organization and report on KPIs regularly.

·       Communicate with external experts to bring enhancements to Medical Affairs processes. Ensure alignment of Medical Affairs work to corporate Standard Operating Procedures. Responsible for defining and maintaining the standards and process of Project Management.

·       Oversee contract and vendor management. Serve as facilitator of legal and purchasing processes and assist in vendor contract negotiation, performance management, maintenance and tracking of master service agreements, work orders, and contracts.

Education and Experience

·       PharmD or Medical Degree (MD) from accredited US or foreign medical school required

·       Strong general knowledge of rare diseases required 

·       At least 8 years of experience in Medical Affairs with a pharmaceutical company

·       At least 5 years of experience with medical information function both outsourced and insourced

·       At least 2 years of managerial experience in medical information

·       Experience with developing medical information standard and custom response documents

·       Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing medical information in post-marketing products

·       Start-up or small company experience strongly preferred

Knowledge and Skills

·       Ability to build an excellent partnership with an outsourced partner, maintaining strong relationships while simultaneously holding the outsourced partner to high standards

·       Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details

·       Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members

·       Fluent in English (oral and writing)

·       Initiative and self-motivation abilities

·       Flexible and adaptable

·       Well organized

·       Positive thinking and enthusiasm

·       Able to work in a small–mid size company

·       Familiarity with medical review processes

·       Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, as well as Veeva systems

·       Demonstrated ability to manage multiple competing priorities