Kendra Hughes Email and Phone Number

• Partner with stakeholders to ensure delivery of all assigned medical activities to support launch and life cycle management of respiratory assets including review of medical responses, dossier development, training, promotional material review.• Ensure the US environment needs are represented and incorporated into global planning for medicinal evidence generation.• Meet regulatory requirements and contribute to the preparation of NDA Annual reports.• Support US medical affairs… Show more • Partner with stakeholders to ensure delivery of all assigned medical activities to support launch and life cycle management of respiratory assets including review of medical responses, dossier development, training, promotional material review.• Ensure the US environment needs are represented and incorporated into global planning for medicinal evidence generation.• Meet regulatory requirements and contribute to the preparation of NDA Annual reports.• Support US medical affairs matrix team, US medical commercial team, and US medical affair leads.• Maintain deep product knowledge and disease understanding; interpret and apply the external environment landscape and competitive information in all medical plans. Show less

• Developed AMCP dossiers.• Created medical responses based on published information and company data.• Developed promotional slide presentations and scientific presentations for use by Medical Science Liaisons and Health Outcome Liaisons.• Reviewed promotional material to ensure scientific credibility, medical accuracy and regulatory requirements were met.• Responded to medical inquiries from healthcare providers.• Trained Medical Science Liaisons, Health Outcome Liaisons… Show more • Developed AMCP dossiers.• Created medical responses based on published information and company data.• Developed promotional slide presentations and scientific presentations for use by Medical Science Liaisons and Health Outcome Liaisons.• Reviewed promotional material to ensure scientific credibility, medical accuracy and regulatory requirements were met.• Responded to medical inquiries from healthcare providers.• Trained Medical Science Liaisons, Health Outcome Liaisons and sales representatives on GlaxoSmithKline products. Show less

• Wrote standard response documents based on published literature and company data.

• Managed operations of seven medical information projects as outsourced vendor for pharmaceutical companies.• Implemented new project operations.• Ensured quality operations through development of SOPs and compliance with all FDA regulations.• Handled personnel management, including performance development, salary administration, hiring, and employee relations.• Ensured appropriate invoicing to clients and management of financial goals for the project.

• Managed 8 to12 consultant pharmacists and nurses on medical information line for pharmaceutical company. Responsibilities included staff management, consultant development, and administrative duties.• Oversaw operations of various therapeutic areas within medical information/customer service department for pharmaceutical company; ensure quality responses for all inquires.• Served as liaison between PPD and pharmaceutical manufacturer; communicate on daily basis with medical… Show more • Managed 8 to12 consultant pharmacists and nurses on medical information line for pharmaceutical company. Responsibilities included staff management, consultant development, and administrative duties.• Oversaw operations of various therapeutic areas within medical information/customer service department for pharmaceutical company; ensure quality responses for all inquires.• Served as liaison between PPD and pharmaceutical manufacturer; communicate on daily basis with medical information associates, product safety associates, and technical services. Show less

• Responded to medical and technical inquiries for large pharmaceutical company.• Provided drug information for various therapeutic areas including Women’s Health, Endocrine, and Critical Care.• Collected serious and non-serious adverse events and documentation into Clintrace database.• Documented and processed product complaints.• Replied to non-verbal medical inquiries from sales force.