Manager, Medical Communications Location San Rafael, California Apply
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.
Global Medical Affairs (GMAF) is an expert scientific and medical function within BioMarin's R&D organization 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, support of continuous scientific exchange and through ongoing and new data generation.
The Medical Communications group is responsible for leading the scientific publication efforts across GMAF. These publications are a critical element in the dissemination of scientific and clinical data to healthcare providers, enabling them to provide the best possible care to their patients. Medical Communications facilitates the development of the publication strategies and plans based on cross functional efforts to understand and analyze scientific knowledge gaps and create scientific messaging platforms. Once the publication plan is established, Medical Communications conducts in-depth statistical analysis of supporting data, performs systematic literature analysis and manages a team medical writers and graphic designer to deliver best-in-class abstracts, posters, oral presentations and manuscripts.
The Manager role provides management and oversight of publication processes, best practices and the publication development and management software, including training and support to GMAF team members. This position will coordinate efforts for the publication development process by maintaining timelines, generating reports, planning meetings, providing support to Medical Affairs members on the publication development process and ensuring compliance with institutional guidelines and policies. The Manager will also be involved in overseeing publishing activities and congress planning and preparation.
Manage publication development activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals
Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP)
Maintain and optimize Datavision, including keeping user, drug, and study information up-to-date, maintaining workflow and email templates, managing built-in filtering and reporting capabilities (i.e. for publication plans, Sunshine Act reporting, and miscellaneous system queries), and monitoring integration with the internal publication review and approval system, Clear
Provide support to internal and external Datavision users ensuring best practices are leveraged; help with initial and ongoing training including creating and revising training materials to keep current with process changes and software upgrades
Periodically audit Datavision to determine completeness of records and level of compliance with industry guidance; use the results to identify potential areas for process improvement
Represent Medical Communications in all decisions related to Clear, the internal publication review and approval system to ensure that our needs are met and the system remains compatible with Datavision and industry guidance for publication development (i.e. GPP and ICMJE authorship guidelines)
Manage scientific congress logsitics
Assist with maintaining the scientific message platforms and gap analyses which inform our publication strategy
Perform literature searches in MEDLINE, Embase and Scopus and obtain corresponding documents as needed
Participate in publication planning meetings to assist with execution of the publication plans
Maintain and improve Medical Communications standard operating procedures and work instructions
Other tasks as assigned
Experienced user of Datavision publication management software
Thorough understanding of GPP3 and ICMJE authorship guidelines
Proficiency in conducting systematic literature searches
Strong interpersonal, customer service and communication skills
Ability to perform many tasks under tight deadlines and maintain attention to detail
Strong organizational and time management skills
Proficiency with Microsoft Office applications (Outlook, Word, Excel, PowerPoint
Understanding of biotech/pharmaceutical clinical development and regulatory processes
3 or more years of relevant experience in medical communications/publication planning
One year or more of people management experience preferred
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.