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. They assure that review materials contain appropriate, robust, accurate (medically/scientifically), and current references. They are also 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. Additionally, they are 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. 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. Responsible for the oversight of the vendors engaged in these activities.
- Develop standard processes related to Medical Information services.
- Independently create new Standard Responses (SRs) and update existing SRs based on an understanding of in-house data and the medical literature.
- Support 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, ensuring alignment with the overall Medical Affairs Plan and Brand strategy.
- Lead and manage medical affairs pharmacovigilance and literature monitoring, including literature safety monitoring for oncology products, and providing literature updates and annotated summaries of key articles.
- Train 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.
- Perform critical analysis and synthesis of internal/external literature.
- Provide 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 a 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 professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
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