BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc. is hiring: Technical Writer 1 in Nov...
BioMarin Pharmaceutical Inc. - Novato, CA, United States, 94998
Work at BioMarin Pharmaceutical Inc.
Overview
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Overview
Description
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 Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
SUMMARY
The Technical Writer position supports manufacturing in the creation and/or revision of procedures (SOPs), batch records (BRs), component-specific raw material specs, best practice documents (BPDs), work instructions (WIs), and job aids pertaining to upstream, downstream, and/or solution preparation process operations, and supplier change notifications. This includes working with manufacturing subject matter experts and other departments to ensure document accuracy and detail. The technical writers are responsible for initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified corrective actions and preventive actions.
This position involves interaction with cross-functional departments within BioMarin Technical Operations. The technical writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), SOPs, corporate policies, and safety practices.
RESPONSIBILITIES
••Write and revise document types listed above, facilitate the review and approval of documents in Veeva QualityDocs in a collaborative manner and within established timelines
••Ensure documents are and consistent with internal style guidelines for format, clarity, flow, organization, and readability
••Manage work independently with support from the other Manufacturing Technical Writer to ensure timely implementation of documentation workflows
••Lead work and engage with business partner departments to achieve departmental or organizational objectives
••Work with manufacturing management, MSAT, Engineering and/or QA Operations to establish comprehensive implementation plans for document revisions and associated change requests
•Interact with appropriate departments to establish priorities and deadlines for revisions
••Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintain
••Other duties as assigned
EXPERIENCE
Required Skills:
Desired Skills:
SHIFT DETAILS
Day shift business hours
This is a flexible role requiring a minimum of two-three days onsite. Tuesday is a mandatory onsite workday.
TRAVEL REQUIRED
This position does not require any regular travel.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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.
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 Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
SUMMARY
The Technical Writer position supports manufacturing in the creation and/or revision of procedures (SOPs), batch records (BRs), component-specific raw material specs, best practice documents (BPDs), work instructions (WIs), and job aids pertaining to upstream, downstream, and/or solution preparation process operations, and supplier change notifications. This includes working with manufacturing subject matter experts and other departments to ensure document accuracy and detail. The technical writers are responsible for initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified corrective actions and preventive actions.
This position involves interaction with cross-functional departments within BioMarin Technical Operations. The technical writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), SOPs, corporate policies, and safety practices.
RESPONSIBILITIES
••Write and revise document types listed above, facilitate the review and approval of documents in Veeva QualityDocs in a collaborative manner and within established timelines
••Ensure documents are and consistent with internal style guidelines for format, clarity, flow, organization, and readability
••Manage work independently with support from the other Manufacturing Technical Writer to ensure timely implementation of documentation workflows
••Lead work and engage with business partner departments to achieve departmental or organizational objectives
••Work with manufacturing management, MSAT, Engineering and/or QA Operations to establish comprehensive implementation plans for document revisions and associated change requests
•Interact with appropriate departments to establish priorities and deadlines for revisions
••Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintain
••Other duties as assigned
EXPERIENCE
Required Skills:
- Experienced report writer who can organize information, defend complex concepts, and adhere to spelling, grammar, and style requirements.
- Can manage time and competing priorities to meet deadlines.
- Proficient with standard Microsoft applications, including Word, Excel, and PowerPoint.
- Practices effective communication and manages relationships with stakeholders and business partners.
- Has an aptitude for problem solving and analysis.
- 2+ years of technical writing
Desired Skills:
- Experience working in a regulated environment.
- Understands the function and mechanical concepts of equipment commonly used to manufacture biologics.
- Working experience with Veeva QMS and Veeva QualityDocs
- Experience writing or revising GMP procedures for frontline workers.
SHIFT DETAILS
Day shift business hours
This is a flexible role requiring a minimum of two-three days onsite. Tuesday is a mandatory onsite workday.
TRAVEL REQUIRED
This position does not require any regular travel.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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.