Clinical Dynamix
Director Medical Information & Operations
Clinical Dynamix, Trenton, New Jersey, United States
Director Medical Information & Operations
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. Responsibilities
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 the medical affairs organization and report on KPIs regularly. Communicate with external experts to bring enhancements to Medical Affairs processes and ensure alignment with corporate Standard Operating Procedures. Define and maintain standards and processes for Project Management. Oversee contract and vendor management, and facilitate legal and purchasing processes, including vendor contract negotiation and management of master service agreements, work orders, and contracts. Education and Experience
PharmD or Medical Degree (MD) from an accredited US or foreign medical school required Strong general knowledge of rare diseases 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 ensuring high standards Ability to work independently, multi-task, and work effectively under pressure; strong project management and attention to detail Excellent interpersonal, active listening, and influencing skills; professional relationships Fluent in English (oral and writing) Initiative and self-motivation 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 with proficiency in Microsoft Excel, Word, PowerPoint, and Veeva systems Demonstrated ability to manage multiple competing priorities Seniority level
Director Employment type
Contract Job function
Research and Science Industries
Pharmaceutical Manufacturing and Biotechnology Research Bernardsville, NJ; $114,100.00-$150,000.00
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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. Responsibilities
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 the medical affairs organization and report on KPIs regularly. Communicate with external experts to bring enhancements to Medical Affairs processes and ensure alignment with corporate Standard Operating Procedures. Define and maintain standards and processes for Project Management. Oversee contract and vendor management, and facilitate legal and purchasing processes, including vendor contract negotiation and management of master service agreements, work orders, and contracts. Education and Experience
PharmD or Medical Degree (MD) from an accredited US or foreign medical school required Strong general knowledge of rare diseases 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 ensuring high standards Ability to work independently, multi-task, and work effectively under pressure; strong project management and attention to detail Excellent interpersonal, active listening, and influencing skills; professional relationships Fluent in English (oral and writing) Initiative and self-motivation 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 with proficiency in Microsoft Excel, Word, PowerPoint, and Veeva systems Demonstrated ability to manage multiple competing priorities Seniority level
Director Employment type
Contract Job function
Research and Science Industries
Pharmaceutical Manufacturing and Biotechnology Research Bernardsville, NJ; $114,100.00-$150,000.00
#J-18808-Ljbffr