BioMarin Pharmaceutical Inc.
CW) Sr Medical Writer (TEMPORARY)
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 to understand the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. BioMarin develops medicines for patients with significant unmet medical need through genetics and molecular biology, with a pipeline that includes commercial, clinical and preclinical candidates that may offer first-to-market advantages or substantial benefits over existing therapies. BioMarin Worldwide Research and Development (WWRD) encompasses research, discovery and post-market development to support first-in-class and best-in-class therapeutics for patients with genetic diseases. 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 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 for regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in document preparation, 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 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 Fulfills one of the following: Up to 6 years of as a medical writer in the pharmaceutical industry; or 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, clinical study 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. 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). 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 coding dictionaries (MedDRA, WHO Drug). Computer/Office Skills Proficient in Microsoft Word (including templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint. Experience using document management software (e.g., LiveLink, SharePoint, Veeva). Experience with scanners, printers, and copiers. Regulatory Intermediate to advanced knowledge of regulatory requirements and guidances for standalone regulatory documents (e.g., 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 Safety and Efficacy summaries (ISS/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 review and comment adjudication stages of document preparation. Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and collaborating with line management to resolve cross-functional conflicts. Good conflict management skills, motivated, detail oriented, and with strong communication skills. Other Capable of well-organized, concise and clear written and verbal communication; ability to translate complex scientific concepts into regulatory-compliant text; intermediate to advanced presentation skills. 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. In the U.S, the salary range for this position is $95,800 to $143,600 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on geographic region, job-related knowledge, skills, and experience amongst other factors. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, 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. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 to understand the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. BioMarin develops medicines for patients with significant unmet medical need through genetics and molecular biology, with a pipeline that includes commercial, clinical and preclinical candidates that may offer first-to-market advantages or substantial benefits over existing therapies. BioMarin Worldwide Research and Development (WWRD) encompasses research, discovery and post-market development to support first-in-class and best-in-class therapeutics for patients with genetic diseases. 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 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 for regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in document preparation, 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 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 Fulfills one of the following: Up to 6 years of as a medical writer in the pharmaceutical industry; or 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, clinical study 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. 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). 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 coding dictionaries (MedDRA, WHO Drug). Computer/Office Skills Proficient in Microsoft Word (including templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint. Experience using document management software (e.g., LiveLink, SharePoint, Veeva). Experience with scanners, printers, and copiers. Regulatory Intermediate to advanced knowledge of regulatory requirements and guidances for standalone regulatory documents (e.g., 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 Safety and Efficacy summaries (ISS/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 review and comment adjudication stages of document preparation. Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and collaborating with line management to resolve cross-functional conflicts. Good conflict management skills, motivated, detail oriented, and with strong communication skills. Other Capable of well-organized, concise and clear written and verbal communication; ability to translate complex scientific concepts into regulatory-compliant text; intermediate to advanced presentation skills. 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. In the U.S, the salary range for this position is $95,800 to $143,600 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on geographic region, job-related knowledge, skills, and experience amongst other factors. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, 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. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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