Senior OR Executive Director, Medical Information

Title:                                     Senior or Executive Director, Medical Information
Reports To:                      Senior Vice President, Medical Affairs
Location:                          Redwood City, CA or Remote
Classification:               Exempt

 
Overview:

The Senior or Executive Director, Medical Information is a vital member of the Medical Affairs team who will oversee the development and execution of medical information strategies and plans in oncology. This highly visible role will engage key thought leaders while collaborating cross-functionally with Project teams, Clinical Development, Product Safety and Pharmacovigilance, Commercial (Marketing and Operations), Quality Assurance and the broader Medical Affairs team.

This person is responsible for ensuring medical accuracy for promotional and medical materials, working in collaboration with the Medical Director. He/she/they assures that review materials contain appropriate, robust, accurate (medically/scientifically), and current references. Also, he/she/they are responsible for maintaining and delivering quality written responses to medical information inquiries and ensuring that the Medical Information Call Center team complies with regulatory policies and procedures. He/she/they is also responsible for surveying the medical literature for relevant new data in disease states of interest to ensure medical information materials are medically accurate and clinically impactful when responding to inquiries.  This person’s responsibilities will include but are not limited to the development of clinically focused responses to medical information requests, dossier and compendia submissions, literature safety monitoring, medical literature searches, annotations of key published literature, as well as supporting medical affairs advisory board’s strategy and content.  

Roles and Responsibilities:

• Lead and expand the Medical Information Call Center in collaboration with Safety and Pharmacovigilance, Quality, Commercial (Marketing and Operations), Product Complaints, and Product Replacements.  In addition, this position will be responsible for the oversight of the vendors engaged in these activities.
• Develops stand process related to Medical Information services
• Independently creates new Standard Responses (SRs) and updates existing SRs based on an understanding of in-house data and the medical literature
• Supports Promotional/Medical Review Committee meetings by participating in the review and approval of promotional/medical materials to ensure medical accuracy.
• Become a subject matter expert and internal liaison for oncology and marketed and pipeline products
• Lead and manage the execution of the medical information strategies for oncology, with an understanding of how these activities support the overall Medical Affairs Plan in alignment with the Brand strategy
• Lead and manage medical affairs pharmacovigilance and literature monitoring including literature safety monitoring for our oncology products as well as providing literature updates and annotated summaries of key articles
• Trains sales team on Medical Information processes.
• Ensure the delivery of high-quality, fair-balanced, scientifically/clinically accurate medical information and communications deliverables in accordance with established timelines, compliance guidelines/policies, and budgets
• Performs critical analysis and synthesis of internal/external literature.
• Provides coverage for the Medical Information booth at US and International medical conferences.
• Lead special projects as needed

Basic Qualifications:

• Doctoral level degree (Ph.D., Pharm.D., or M.D.) in life sciences with minimum of 5 years bio-pharmaceutical medical information industry experience within Medical or Clinical Affairs
• Excellent written and verbal communication skills, with the ability to understand and effectively communicate complex scientific and clinical data to internal and external stakeholders

 Preferred Qualifications:

• Prior Oncology experience preferred
• Experience in Medical Information, Medical Communications, and Pharmacovigilance
• Ability to collaborate internally and build solid working relationships cross-functionally
• Highly organized with the ability to manage multiple projects simultaneously, think critically, and adhere to tight deadlines.
• Demonstrated functional knowledge of applicable guidelines including ICMJE, ACCME, OIG, PhRMA, GPP & GCP

The Base Salary Range for this position is $230,000 - $290,000. Coherus considers various factors, including p