Associate Medical Affairs Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
Job Description – Manager, Medical Affairs Operations and Quality
The Manager of Medical Affairs Operations and Quality Latin America is responsible for the management, quality and operation of all Medical Affairs Latin America programs, having interface with internal and external stakeholders.
- Organize the medical plans consistent with BioMarin Medical Affairs strategic objectives, working closely with the medical leaders in Latam North, South, CAAC and Brazil.
- Establish a high level of working knowledge and contribute to the management of Medical Affairs programs across all therapeutic areas.
- Organize and execute contracts and annual budgets (forecast, reforecast) related to Advisory Boards, Phase III and IV studies, Consulting Agreements, Medical Grants etc.
- Facilitates submission and management of relevant non-promotional Medical Affairs materials to Medical Materials (MMRC) review process across all therapeutic areas; adjustment of the reviewed material per Compliance-Legal, Medical and Regulatory according to the comments or communicate required changes to appropriate contact (Veeva Vault platform)
- Create agendas for weekly meetings and provide meeting summaries and tasks update to all Medical Sciences members.
- Assist in preparing/formatting reports and/or presentations/slide decks that showcase metrics across all therapeutic areas and programs within Medical Sciences in Latam
- Compile and reporting data regarding Sunshine Act to Compliance on a monthly basis across all programs and communicate with external requestors on obtaining appropriate information when required
- Maintain an accurate and organized record of business, strategic and scientific information e.g. Medical agreements, contracts, training records, sites visits, certifications, medical educational grants, diagnostic laboratories.
- Provide operational guidance to Latin America’s interface and manage ad hoc operational issues as needed
- Keep abreast of industry best practices and trends and regularly provide process recommendations
- Leads the logistic and organizational aspects of medical affairs activities and meetings with both internal and external stakeholders, e.g., CRO, KOLs
- Support to Medical Leaders and MSLs in key metrics and visits reports
- Interface with Medical Leaders supporting them on KOLs development plan and mapping in Latin America
- Support new hires MAF training on boarding coordination
- Develop, implement and maintain Standard Operating Procedures (SOPs), Work Instructions (WI), Internal Guidelines (IG) and Memorandum of Understand (MoU) to promote high quality, efficient, and compliant systems.
- Experience in managing clinical studies
- Sound knowledge of GCP guidelines
- Experience in developing Standard Operating Procedures, and assessing for required updates according to company needs and changes in legislation
- Bachelor of Sciences in clinical area (ie Pharmacy, Nurse, Medicine, Biology, BioMedicine
- Post Bachelor degree in Clinical Trials/Medical Affairs, Pharmaceutical Medicine or related areas
- + 5 years Pharmaceutical Industry and Clinical trial experience preferred
- Fluency in English and good knowledge of Spanish
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.