The Director of Medical information is responsible for leading the creation and management of Medical information and Call Center Capability at ONYX. Candidate will be a member of the Senior Leadership Team within Medical Affairs and based in South San Francisco, California. This position is responsible for directing and leading the activities and functional capabilities of the Medical Information and ensuring that the Medical Information team executes against department/company strategy and objectives. The candidate will lead the development of Medical Information standard/letters, FAQs, participation in copy review committee, sales training initiatives, medical congress support and all other related business initiatives throughout lifecycle of a product. He/ She would serve as the expert and knowledgeable resource for the medical information group as well as internal business partners. - Leads the implementation of Medical Information Mgt System, overall infrastructure, policies and procedures for the department. In addition, is responsible for Managing and training the Medical Information and Call Center vendor(s).
- Oversees the general operations of Medical Information and Call Center to ensure high quality responses and support for the continuous process improvement. Utilizes effective project and people management skills to ensure achievement of department goals and objectives. - Identifies and prioritizes potential issues within the operations of the department and communicates and supports key stakeholders to develop the appropriate action plans for emergent and unexpected events ( label change, safety, product stability etcâ?¦)- Reviews and approves standard response letters and other product information documents to ensure accuracy, currency, and fair-balance of all clinical information provided by Medical Information staff. - Liaises with other Medical Affairs line functions to effectively manage projects.
- Interacts with Sales Training to identify trends and coordinates departmental participation in review of sales training materials, including presentations and overall clinical training. - Ensures awareness of current trends within the industry. Identifies benchmarks and establishes best practices within the Medical Information group.
- Provides input and participates in decisions that affect the overall budget, resourcing strategies, functional capabilities, and operations of the Medical Information group.
- Creates and implements departmental SOPs, guidelines and procedures necessary to achieve organizational and compliance objectives. Evaluates adherence to policies/procedures and institutes corrective action when needed. - Conducts business in accordance with ONYX Values.
Bachelor's DegreeAND2+ years of proven leadership experience OR 5+ years of scientific affairs experiencePreferred QualificationsDoctorate level degree (Pharm D, MD, PhD) required.- Oncology training/experience preferred.- Minimum of 12+ years experience in building and managing medical information and biotech/pharmaceutical industry experience.
- Candidate will be managing Med Info managers, coordinators and Call Center vendors.- Great understanding of Pharmaceutical industry- Knowledge of regulatory and legal issues and compliance- Knowledge and understanding of relevant clinical and therapeutic issues.- Knowledge of Med Info trends and technologies- Ability to create and present on scientific and clinical data.- Demonstrated record of leadership, and people Management expertise
- Ability to work with multidisciplinary teams
- Excellent written, verbal and interpersonal communication skills
- Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively and communicate at all levels within the company
- Some travel required (20
- 30%) to represent company at medical conferences, presentations, and other meetings
- Dynamic, self starter with strong influential skills- Excellent written and verbal communication skills- Exceptional organization and project planning skills- Strong interpersonal skills and the ability to relate and work with a wide range of people to achieve results- Willing to work in cross-functional environment- Team player with ability to collaborate with others to accomplish goals, adaptable to change- Ability to manage multiple projects in a fast paced environment Onyx is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.