Essential Functions of the job:
Demonstrate scientific and business expertise relevant to the therapeutic area,including product, disease state management, emerging therapies, and the competitive landscape.
Monitor the medical environment (including medical inquiries) and apply scientific expertise, integrated with regulatory and compliance knowledge, to impact Brand/Therapeutic Area strategy support.
Provide scientific training to the Brand/Therapeutic Area Medical Information colleagues and in preparation for launch.
Lead the development of the content for the Medical Information booth at scientific conventions and provide staffing support conventions.
Support MRC activities related to medical information
Responsible for the development and approval of Standard Response Letters (SRL) and FAQs in response to unsolicited requests from HCPS.
Collaborate with key stakeholders to identify scientific information to meet customer needs and Field Medical support.
Manage vendor (s) and the medical information call center
Scientific Content/Brand Support:
Accountable for Medical Information contribution to promotional review and provide strategic scientific consult on brand messages, review promotional materials for content and accuracy, Contribute to the prioritization of review for promotional materials.
Coordinate development, review and approval of clinical Data on File Packets to support promotional claims.
Lead / Coordinate the Medical review committee and contribute to development, review and maintenance of Medical Affairs Scientific materials, including Managed Market documents, in collaboration with Medical Affairs colleagues.
Incorporate customer insight to identify, update, and develop scientific materials.
Coordinate and collaborate with Medical Affairs colleagues, vendors and agencies to develop scientific content for medical materials.
Participate in Medical Affairs training initiatives including:
Provide consult to Medical Affairs key stakeholders and vendors to shape the content and development of training materials
Develop the content for brand scientific training in conjunction with Medical Affairs Training Team where applicable
Coordinate, create, and/or review submissions to external Drug Information.
Resources and Evidence-Based Practice Centers.
Lead the compendia submission process for Medical Affairs.
Provide consult to Regulatory/Labeling committee and the US publications team on brand publication.
Respond to Medical Inquiries and engage in appropriate scientific information exchanges with Health Care Providers via multiple channels (i.e. verbal, written).
Manage accurate, focused, and scientifically balanced clinical and scientific.
information exchanges with Health Care Providers that support the appropriate use of and clinically differentiate our products.
Identify, analyze and/or report trends in medical and scientific insight (including Medical Inquiries) to Medical Affairs stakeholders
5-7 years of experience.
Experience in hematology/oncology or immuno-oncology preferred.
Education Required: Degree in a scientific discipline. Advanced degree is required Pharm.D. or PhD. 5-7 years of experience within the pharmaceutical industry, a consulting organization, and/or a medical communications company Medical Information. Clinical Pharmacy experience with patient care exposure and Drug Information Residency or equivalent experience is strongly preferred.
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
Flexibility to work with colleagues in a global setting
Capabilities and Competencies:
Strong project management skills
Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and within multi-disciplinary teams.
Understand the clinical development process, especially clinical study data and outcome measures in hematology/oncology.
Ability to critically appraise and apply knowledge gained from the medical/scientific literature.
Strong interpersonal skills for effective professional communications, aiming to cultivate strong working relationships with both internal and external groups.
Ability to effectively communicate complex medical/scientific information.
Proficiency with Microsoft Office applications (e.g., Outlook, Excel, Power Point) is required, as well as familiarity and working knowledge of key software applications relevant to publication planning and implementation
Level of position commensurate with experience.
Locations: Emeryville, CA or San Mateo, CA
Travel: Work related travel approximately 25% - 40 %
Ethics Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds BGNE organizational values
Planning/Organizing Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management Communicates changes and progress; Completes projects on time and budget.