Position: Director/Sr. Director, Global Medical Affairs - Diabetes (Insulin) Job 2455
Location: Northern NJ: Hybrid Schedule - 2 days in office, 3 days WFH
Compensation: Based Upon Experience: $180K - $200K + 20% bonus
Summary: This individual leads the global medical affairs team (China and U.S) that supports the Company’s compound portfolio. This will include leading Medical Affairs Strategy for all of its Compounds as well as Medical Communications, Medical Information, and External Scientific Engagement. In addition to leading the Medical Affairs team, this position will take an active role in Medical Communications and External Scientific Engagement as part of a growing Medical Affairs Team.
Responsibilities:
Provides medical support to the research and development, clinical development, and all pre-launch, launch and post-launch activities across the company’s portfolio
Leads the external scientific engagement for the organization across the portfolio (i.e key opinion leaders, external scientific professional organizations, patient advocacy groups, congresses)
Leads the evidence generation for the organization (competitive intelligence, RWE, Investigator-initiated studies, Target product profile, medical affairs plan and etc)
Leads Medical Excellence for the organization (training, medical information, publications, field teams and etc.)
Create and deliver timely responses to unsolicited medical information inquiries/requests from HCPs in a multimedia environment and record information according to the Company’s Standard Operating Procedures and regulatory guidelines
Build and launch a strategic engagement plan for key external experts and collaborations with external scientific professional organizations.
Evaluate medical grant requests on both content and compliance with all internal and external policies, and regulations working with cross-functional colleagues
Responsible for the development and implementation of medical education and congress materials
Create and deliver timely responses to unsolicited medical information inquiries/requests from HCPs in a multimedia environment and record information according to the Company’s Standard Operating Procedures and regulatory guidelines
Generates inquiry to ‘standard response’ and ‘frequently asked questions’ documents, incorporating local preferences when needed, while ensuring the core consistency of responses
Leads external messaging to the medical community for congresses and other external engagements, and ensures consistent corporate branding, messaging, tone, visual cohesiveness, and compliance
Manage internal review and approval process for all SRL and FAQs
Manage an annual review schedule for all SRL and FAQ documents
Generates inquiry metrics for the specified reporting period; highlighting trends and identifying needs and solutions as appropriate to help meet inquirer needs. Ensures accuracy of reported information.
Requirements:
A PhD or MD is required. Pharm.D. is also acceptable.
At least 8 years in providing medical affairs support gained working for pharmaceutical, biotechnology, or CRO company.
Deep knowledge and experience in leading Medical Affairs
Deep knowledge of clinical development and regulatory agencies for new compound entities and biosimilars and biologics.
Experience in working in a multi-culture/multi-countries environment is preferred.
Experience in diabetes (i.e insulins) is desired
Demonstrated ability to manage multiple and diverse projects concurrently.
Demonstrated ability to develop positive relationships and collaborations both internally and externally.
A global mindset is required, ability to partner cross-functionally.
Desired to participate in creating Medical communications and Medical Information
Ability to create a relation
Proven ability to work with vendors and maintain positive relationships.
Strong analytical skills; a strategic thinker, planner, and implementer.
Ability to operate independently with minimal supervision.
Excellent written and oral communication skills and a command of the English language.
Strong proficiency in Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.