BIOMARIN is hiring : Associate Director, Clinical Medical Writing in San Rafael

Who We Are

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. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

Our Culture

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

Summary

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).

Responsibilities

• 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
• Works with CMW line management to establish and maintain timelines for program planning.
• 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
• Builds effective partnerships with cross-functional groups to ensure customer / stakeholder needs are met.
• For outsourced projects, performs vendor management tasks (including but not limited to reviewing contract proposals, conducting interviews, preparing and conducting onboarding sessions, and providing oversight for external writers)
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (e.g. PSURs, DSURs)
• Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2 / Module 5 clinical or integrated summaries).
• Manages study team participation in the preparation of such documents, including calling / running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Oversees development and review of standard processes and templates within Clinical Medical Writing, and may also review / consult on the development of standard processes and templates in other departments
• Works effectively with cross-functional groups within BioMarin
• Other tasks as assigned.

Education & Experience

Relevant Experience

Fulfills one of the following :

At least 10 years of experience as a medical writer in the pharmaceutical industry

Management

Clinical Studies

o documentation required for the conduct of clinical studies

o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)

o study results reporting

o integrated results reporting

Medical Writing

o Routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.

o Interpreting data from tables, graphs, and listings

o Creating in-text data presentations (including complex tabular and graphical clinical data presentations)

o Interpreting basic clinical laboratory tests

o Researching literature

o Understanding concepts of coding dictionaries (MedDRA, WHO Drug)

o Preparing high-quality clinical and regulatory documents (protocols, IBs, clinical study reports, ICFs).

Computer / office equipment Skills

Regulatory

o ‘standalone’ regulatory documents (e.g. protocols, investigator brochures, clinical study reports, IND annual reports)

o Clinical sections of pre-submission meeting packages (e.g. pre-IND or end-of-Phase 2 meetings), Orphan Drug Applications, CTAs, IMPDs, etc.

o Targeted Product Profile, Package Inserts / Product Labels (using structured product labeling guidelines)

o Responses to FDA queries and inspection findings

Project Management

Communication

Note : This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer / Veterans / Disabled

An Equal Opportunity Employer. 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.

The salary range for this position is : $149,400 to $224,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit : https : / / careers.biomarin.com / benefits .

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