BioMarin Pharmaceutical Inc.
Senior Medical Writer
BioMarin Pharmaceutical Inc., San Rafael, California, United States, 94911
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 sub‑teams)
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
Scope This position progressively develops the medical writing function in alignment with the requirements of 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
Up to 6 years as a medical writer in the pharmaceutical industry
At least 10 years of medical or scientific writing experience 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 dataset generation
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
Intermediate to advanced applied knowledge of documentation required for the conduct of clinical studies, protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs), 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 required
Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
Experience writing, reviewing, or editing regulatory briefing books preferred
Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced applied knowledge of basic clinical laboratory tests
Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Computer/Office Equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint
Experience using document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers
Regulatory
Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports)
Prior familiarity with standard eCTD IND/NDA work, including Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
Project Management
Capable of working on multiple tasks and shifting priorities
Capable of leading a cross‑functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation
Capable of representing Global Medical Writing at cross‑functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross‑functional conflicts
Good conflict management skills
Motivated and shows initiative
Detail oriented
Communication
Capable of well organized, concise and clear written and verbal communication
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements
Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced 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, or protected veteran status and will not be discriminated against on the basis of disability.
Salary and Benefits 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. 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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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 sub‑teams)
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
Scope This position progressively develops the medical writing function in alignment with the requirements of 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
Up to 6 years as a medical writer in the pharmaceutical industry
At least 10 years of medical or scientific writing experience 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 dataset generation
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
Intermediate to advanced applied knowledge of documentation required for the conduct of clinical studies, protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs), 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 required
Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
Experience writing, reviewing, or editing regulatory briefing books preferred
Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced applied knowledge of basic clinical laboratory tests
Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Computer/Office Equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint
Experience using document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers
Regulatory
Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports)
Prior familiarity with standard eCTD IND/NDA work, including Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
Project Management
Capable of working on multiple tasks and shifting priorities
Capable of leading a cross‑functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation
Capable of representing Global Medical Writing at cross‑functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross‑functional conflicts
Good conflict management skills
Motivated and shows initiative
Detail oriented
Communication
Capable of well organized, concise and clear written and verbal communication
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements
Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced 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, or protected veteran status and will not be discriminated against on the basis of disability.
Salary and Benefits 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. 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.
#J-18808-Ljbffr