BioMarin Pharmaceutical Inc.
Senior Medical Writer
BioMarin Pharmaceutical Inc., San Rafael, California, United States, 94911
Overview
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 1997, BioMarin has applied scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using expertise in genetics and molecular biology, BioMarin develops medicines for patients with significant unmet medical need. We seek individuals with the right technical expertise and a relentless drive to solve real problems, empowering teams to pursue bold, innovative science. Our approach supports a diverse pipeline of commercial, clinical and preclinical candidates with well-understood biology and potential for first-to-market or substantial benefits over existing options. Note:
This description is not intended to be all-inclusive, or a limitation of the duties of the position. It describes the general nature of the job and may include other duties as assigned.
Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves bench and clinical research and the groups that support those efforts. Our teams work on developing first-in-class and best-in-class therapeutics that meaningfully advance patients with genetic diseases.
Senior Medical Writer – Role
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 (e.g., 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 (e.g., 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 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
Scope
This position progressively develops the medical writing function in alignment with the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
Education 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
Relevant Experience
Fulfills one of the following: Up to 6 years of medical writing in the pharmaceutical industry OR At least 10 years of medical or scientific writing as a primary job responsibility
Clinical Studies: Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, data collection, database management, data integration, and generation of datasets
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
Documentation required for the conduct of clinical studies; protocol design; study results reporting; and integrated results reporting
Direct experience with documentation in all phases of drug development
Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; experience with INDs, BLA/NDAs, PBRERs, DSURs, and PAERs is highly preferred; experience with regulatory briefing books preferred
Advanced knowledge of routine document content preparation, style guides, medical dictionaries, and regulatory guidance
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced knowledge of basic clinical laboratory tests
Understanding of coding dictionaries (MedDRA, WHO Drug)
Technical Skills Proficient in Microsoft Word (templates), Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint
Experience with document management software (e.g., LiveLink, SharePoint, Veeva)
Experience with scanners, printers, copiers
Regulatory Intermediate to advanced knowledge of regulatory requirements and guidances for standalone regulatory documents (protocols, investigator brochures, clinical study reports)
Familiar with eCTD IND/NDA work, including Modules 2, 3, 4, and 5; ISS and ISE
Project Management Ability to work on multiple tasks and shift priorities
Experience leading a cross-functional team under strict timelines, including running meetings and managing document review and comment adjudication
Ability to represent Global Medical Writing at cross-functional meetings and work with line management to resolve cross-functional conflicts
Good conflict management, motivation, initiative, and attention to detail
Communication Clear written and verbal communication
Ability to translate complex scientific concepts into clear, regulatory-compliant text
Strong presentation skills
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, protected veteran status, or disability.
The salary range for this position is: $116,000 to $155,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
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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 1997, BioMarin has applied scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using expertise in genetics and molecular biology, BioMarin develops medicines for patients with significant unmet medical need. We seek individuals with the right technical expertise and a relentless drive to solve real problems, empowering teams to pursue bold, innovative science. Our approach supports a diverse pipeline of commercial, clinical and preclinical candidates with well-understood biology and potential for first-to-market or substantial benefits over existing options. Note:
This description is not intended to be all-inclusive, or a limitation of the duties of the position. It describes the general nature of the job and may include other duties as assigned.
Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves bench and clinical research and the groups that support those efforts. Our teams work on developing first-in-class and best-in-class therapeutics that meaningfully advance patients with genetic diseases.
Senior Medical Writer – Role
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 (e.g., 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 (e.g., 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 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
Scope
This position progressively develops the medical writing function in alignment with the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
Education 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
Relevant Experience
Fulfills one of the following: Up to 6 years of medical writing in the pharmaceutical industry OR At least 10 years of medical or scientific writing as a primary job responsibility
Clinical Studies: Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, data collection, database management, data integration, and generation of datasets
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
Documentation required for the conduct of clinical studies; protocol design; study results reporting; and integrated results reporting
Direct experience with documentation in all phases of drug development
Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports; experience with INDs, BLA/NDAs, PBRERs, DSURs, and PAERs is highly preferred; experience with regulatory briefing books preferred
Advanced knowledge of routine document content preparation, style guides, medical dictionaries, and regulatory guidance
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced knowledge of basic clinical laboratory tests
Understanding of coding dictionaries (MedDRA, WHO Drug)
Technical Skills Proficient in Microsoft Word (templates), Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint
Experience with document management software (e.g., LiveLink, SharePoint, Veeva)
Experience with scanners, printers, copiers
Regulatory Intermediate to advanced knowledge of regulatory requirements and guidances for standalone regulatory documents (protocols, investigator brochures, clinical study reports)
Familiar with eCTD IND/NDA work, including Modules 2, 3, 4, and 5; ISS and ISE
Project Management Ability to work on multiple tasks and shift priorities
Experience leading a cross-functional team under strict timelines, including running meetings and managing document review and comment adjudication
Ability to represent Global Medical Writing at cross-functional meetings and work with line management to resolve cross-functional conflicts
Good conflict management, motivation, initiative, and attention to detail
Communication Clear written and verbal communication
Ability to translate complex scientific concepts into clear, regulatory-compliant text
Strong presentation skills
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, protected veteran status, or disability.
The salary range for this position is: $116,000 to $155,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
#J-18808-Ljbffr