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Medical Director, Medical Affairs Ophthalmology (Science & Biotech)
Irvine, CA 92614
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Apr 06, 2019
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Job Description

Our client, a growing pharmaceutical company preparing for another exciting launch, is currently looking for a Medical Director, Medical Affairs for their growing team. This position can be based in Irvine, CA or in the Bedminster, NJ area.

Responsible to work in close collaboration with the V.P. Medical Affairs to align with the leaders of commercial operations, clinical and regulatory to execute the strategic efforts of Medical Affairs in support of pre-launch, branded and late – stage products, as well as manage the organizational planning and operational needs of the Medical Affairs organization.

Essential Duties and Responsibilities:
Medical Affairs:
• Represent Medical Affairs on MLR (Medical Legal Review) and SRC (Scientific Review) Committees
• Oversee and participate in the review of promotional and educational materials and programs for scientific accuracy.
• Owner of the overall SRC process in terms of process/systems, submissions, and approvals
• Oversee development of post-marketing clinical development plans including phase 3b and phase 4 clinical trials
• Enhance scientific relationships with leaders in markets.
• With VP Medical Affairs, develop annual budget and manage to forecast especially for those initiatives with direct responsibility
• Provide leadership of key functional areas of Medical Affairs (Medical Communications, Medical Education, Medical Affairs Managers)
• Oversee the Continuing Medical Education program
• Ensure Standard Operating Procedures are developed and updated for the department
• Oversee Investigator Initiated study grants and medical education grants process from both a content and compliance purview in collaboration with regulatory affairs and compliance.
• Oversee the development of publications: to include scientific presentations for marketed and specific pipeline products with a strategic focus for the purposes of inclusion in advisory boards, investigator meetings, scientific forums and education (where appropriate and within regulatory guidelines), posters, presentations, publications
• Maintain knowledge of FDA, GCP, and ICH guidelines
• Continually reinforce that all commercial and scientific communications and activities are compliant with Pharma Guidelines and federal statutes
• Medical Affairs Liaison with Regulatory Affairs to review AEs as needed, research appropriate data, work with Regulatory review Safety signals, and external connection to physicians/medical professionals who have inquiries regarding AEs,
• Responsible for oversight of Medical Information Call Center including management of vendor, production of materials (SRLs, FAQs), training of call center personnel, approval of materials and liaison with Regulatory as needed, liaise regarding request with MSL team, and connect as needed with external customers if follow up needed
• Manage multiple projects and activities with minimal supervision by the VP Clinical Research, Medical and Professional Affairs

MEDICAL AFFAIRS CLINICAL TRIALS SUPPORT
• Oversees and ensures strategic alignment with commercial operations in planning and developing phase 3B and phase 4 study programs
• Ensures timelines are developed and met related to completion of trials and publications of results to support commercial needs
• Works with Clinical and Regulatory to ensure that SOP’s are up to date and all the clinical trials meet FDA, GCP and ICH requirements
• Develops the budget and manages the forecast for post-approval clinical studies

• Reports directly to Vice President, Medical Affairs
• Serves as or delegates as appropriate the liaison functions of medical affairs with marketing/sales for all products with respect to medical and scientific strategy and opportunities
• External interface on Medical Affairs matters as appropriate, with health care professionals
• Budget management responsibility and accountability for Medical Affairs department
.
SUPERVISION
• Assesses Department needs and justifies appropriate sizing based upon workload and budgets

PRODUCT COMMUNICATIONS TO HEALTH CARE PROFESSIONALS
• Ensures that medically and scientifically correct information is disseminated to health care professionals while keeping the sales and marketing management informed on the contact and content
• Supervises implementation of targeted medical education symposia or seminars on diseases of interest and pharmacotherapeutics, in compliance with current FDA regulations and Pharma Guidelines
• Provides the corporate communications interface to health care professionals for dissemination of medical and scientific information about products or the diseases/conditions for which each is designed to treat
• Oversees development of materials and leads or delegates leadership of advisory boards, investigator meetings or company sponsored symposia
• Directly accountable for the company’s Continuing Medical Education Grants program
• Oversees management of Medical Affairs Communication materials: presentations, publications, posters, abstracts

MEDICAL REVIEW FOR MARKETED PRODUCT INFORMATION AND COMMUNICATION
• Reviews and approval all product promotional and scientific/medical affairs materials for medical and scientific accuracy and compliance.
• Oversees competitive surveillance for medical and scientific opportunities to expand the scope of indications for products or to facilitate addressing medical needs through product improvements.

DRUG PRODUCT SAFETY SURVEILLANCE AND REPORTING
• Ensures that quarterly and yearly Product Safety Updates are included in external communications to customers
• Ensures that all members of medical affairs are fully informed and compliant with the reporting of Serious Adverse Events received through Medical Affairs and Medical Communications
• Medical Affairs Liaison to Regulatory Affairs to review Adverse Event report, research, communicate with external physicians, patients, customers as needed
• Supervises critical quantitative and qualitative trends in product safety reports to update regulatory authorities and health care professionals in a timely manner as required by regulations.

Minimum Qualifications:
Education and Experience:
• MD and 7+ years related industry experience required, or O.D./PhD/PharmD/Masters Degree plus equivalent experience preferred.
• Prior experience in ophthalmology
• Strong organizational and communication skills are required as well as in-depth knowledge of Medical Affairs, including FDA and international regulations, GCPs, clinical research, conduct of clinical trials,
• Experience managing/overseeing large projects with VP internal staff.
• Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve
• Requires pharmaceutical industry experience across medical affairs functions at the level of Director or higher. A history of successful management of operations and people with a minimum of 8 years’ experience in supervisory / management positions.
• People management 2-3+ years experience with small and large teams, in office and remote and international
Preferred Qualifications (in addition to those noted in Minimum Qualifications section above)
• MD and 10+ years of related industry experience
• Formal training as an ophthalmologist preferred
• Previous people management