Associate Director of Medical Writing
5 days ago
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. The Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program and product development, and other resource or budgetary medical writing requirements for that/those program(s).
Oversight responsibilities for Medical Writing staff.
Works with the Head of Medical Writing to ensure appropriate CMW deliverables planning for specified clinical development program(s), including resource forecasting and allocation, timelines, and budget.
Acts as management-level author/reviewer for CMW and other Development Sciences deliverables, where such review/authoring is required by SOPs or other controlled process documentation.
For outsourced projects, performs vendor management tasks.
Drafts and edits documents used in the preparation of regulatory filings.
Provides peer review and editing support for other regulatory documents.
Oversees development and review of standard processes and templates within Clinical Medical Writing.
scientific focus desirable.
At least 10 years of experience as a medical writer in the pharmaceutical industry.
Evidence of medical writing career development desirable.
At least 10 years of experience as a medical writer in the pharmaceutical industry.
Minimum of 3 years administrative and/or functional management experience.
Experience with budgeting documentation projects.
Experience with delegating and overseeing projects and tasks.
Experience coaching or mentoring medical writers.
Computer/Office Equipment Skills
Proficiency in Microsoft Word, Excel, Adobe Acrobat, and PowerPoint.
Proficiency with MS Project/Project Server.
Experience using document management software.
Regulatory
Ability to plan and manage development of regulatory documents.
Support project teams by identifying and summarizing relevant regulations and guidelines.
Project Management
~ Ability to plan, resource, assign, and keep executive management appraised of the status of multiple simultaneous document development projects.
Effective at explaining writing principles to a varied audience.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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