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.
Global Medical Affairs (GMAF) is an expert scientific and medical function that develops and maintains non-promotional, evidence-based, transparent and balanced scientific and educational programs and resources in support of BioMarin’s products and disease states of interest. We do this by assuring safe and appropriate product use, supporting continuous scientific exchange and through ongoing and new data generation.
The Medical Communications group is responsible for leading the scientific publication and regulatory document development efforts across GMAF. The scientific publications are critical elements in the collection and dissemination of scientific and clinical data to healthcare providers, enabling them to provide the best possible care to their patients, while the regulatory documents help fulfill post-marketing commitments to ensure ongoing patient access to our therapies. The medical writer applies documentation preparation and project management skills to assist in the development, drafting, reviewing, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
The Associate Director supports the Medical Communications regulatory writing function in alignment with the requirements of GMAF and organizational goals. This is an emerging leadership position in Medical Communications with substantial strategic input across GMAF for assigned product(s) or therapeutic area(s). The Associate Director will focus on shaping and defining medical writing activities for assigned products, including synthesizing stakeholder input, ensuring alignment cross-functionally, and conducting gap analyses for defining the writing strategy. The Associate Director will also lead content creation activities including oversight of contract writers and ensure compliance with all BioMarin standard operation procedures. This position may be responsible for supporting Medical Communications functional leadership activities including managing staff, budgets, and departmental activities.
Education & Experience