BioSpace is hiring : Senior Medical Writer in San Rafael

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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.

About Worldwide Research And Development

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.

The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Responsibilities 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 (PBRERs, DSURs, etc.)

Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD 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 Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).

Builds effective partnerships with cross-functional groups to ensure customer / stakeholder needs are met.

Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials

Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review / consult on the development of standard processes and templates in other departments

Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.

Works effectively with cross-functional groups within BioMarin

Other tasks as assigned.

Qualifications & Experience Education

State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

Bachelor’s or higher degree required; scientific focus desirable. Minimum requirement : Experience in medical writing. Evidence of medical writing career development desirable, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

Experience

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

• Up to 6 years of experience as a medical writer in the pharmaceutical industry;

At least 10 years of medical or scientific writing experience as a primary job responsibility in Clinical Studies

Advanced understanding of the drug development process, biostatistical and clinical research concepts, clinical study conduct, data collection, and reporting

Intermediate to advanced understanding of nonclinical development, CMC, PK, PD, and antibody detection

Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA / NDAs, PBRERs, DSURs, and PAERs (highly preferred for some roles)

Proficiency with Word, Excel, PowerPoint, Adobe Acrobat, and document management tools (e.g., LiveLink, SharePoint, Veeva)

Ability to interpret and create complex tabular and graphical data presentations

Ability to lead cross-functional teams, manage timelines, and adjudicate document reviews

Excellent written and verbal communication; detail oriented; able to translate complex science into regulatory-compliant text

Experience with standard eCTD IND / NDA work

Equal opportunity to work in a collaborative cross-functional environment

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.

Seniority level Mid-Senior level

Employment type Full-time

Job function Marketing, Public Relations, and Writing / Editing

Industries Internet News

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