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Global Medical Information Associate Director/DirectorJob Area: R&D/Medical
Job Category: Professionals
Job Site: Hybrid
Location: San Mateo, CA, US
PURPOSE OF THE ROLE Under the direction of the Head of Global Medical Communications, the Associate Director/Director of Global Medical Information will be responsible for leading the biotech medical information function worldwide ensuring the delivery of accurate, timely, and compliant scientific and medical information to healthcare professionals, patients, payers and internal stakeholders. This role combines scientific expertise with strategic leadership to support our company's global medical affairs biotech objectives.
This role is based in our San Mateo, CA office (Hybrid).
ROLES & RESPONSIBILITIES Strategic Leadership & ManagementOptimize achievement of overarching medical information program strategy, including identifying process improvements, instituting best practices, supporting development of tools, templates, and reports, and implementing feedback from team members.
Conduct annual situational analysis to create medical information strategic plan and metrics, and ensure individual team goals set to deploy effective execution against the plan.
Ensure medical information strategy is compliant with industry best practices and applicable regulatory guidelines worldwide.
Lead and mentor a team of medical information professionals with the accountability of executional excellence.
Establish and maintain quality and compliance standards for medical information deliverables.
Collaborate with cross-functional teams including Medical Affairs, Regulatory, Legal, and Commercial to ensure appropriate processes are set up to provide timely medical information responses.
Analyze medical information inquiries to identify trends and insights and provide strategic input on emerging medical/scientific issues.
Maintain an advanced level of therapeutic knowledge (clinical and theoretical) of pathophysiology, diagnosis, drug therapy, standards of care, competitive landscape, and desired patient outcomes in Dompe therapeutic areas of interest.
Ensure scientific accuracy and compliance with medical information responses.
Provide oversight for the development (research, outline, compose, review) and maintenance of standard and custom medical information responses in various formats to address vast array of inquiries.
Ensure delivery of high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
Medical Information Operational ExcellenceOversee the medical information contact center operations including creating and monitoring key operational performance indicators.
Create an annual training curriculum for all medical information specialists and medical information vendors, and ensure documentation against the training is conducted yearly.
Ensure compliance with regulatory requirements and company policies.
Develop and maintain SOPs for medical information processes.
Lead quality assurance programs for medical information activities.
Represent medical information in regulatory and pharmacovigilance inspections and audits.
Develop and maintain medical information databases and resources.
Ensure cross-functional and external vendors are appropriately trained on medical information processes.
REQUIRED QUALIFICATIONS Advanced degree in life sciences (PharmD, PhD, MD, etc) in a scientific discipline preferred.
Minimum 5 years of pharmaceutical/biotech industry experience in the management and oversight of Medical Information required.
Able to work effectively in virtual and multi-disciplinary teams globally.
Vast therapeutic area experience (covering several therapeutic areas at one time).
Deep understanding of pharmaceutical industry regulations and compliance requirements.
FURTHER REQUIREMENTS Proven ability to synthesize large amounts of scientific data in a way where the most important points are understood.
The ability to foster teamwork by actively participating in and supporting an environment that cultivates professional growth and organizational effectiveness.
Exceptional written and verbal communication skills, including the ability to clearly communicate business processes and solutions in person and over the phone.
Highly motivated and self-directed with ability to think innovatively & strategically, skillfully plan, manage and prioritize multiple projects independently; demonstrates resilience and flexibility.
May require up to 15% travel.
$175,000 - $255,000 a year.
At Dompé, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland
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