Medical Writer

b'nnnnnnnn Medical Writer - BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnn nn

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n San Rafaeln

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n BioMarin Pharmaceuticaln

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Medical Writer

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Location: San Rafael, United States

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Workstyle: Hybrid

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Apply

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Who We Are

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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.

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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.

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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 xe2x80x93 people with the right technical expertise and a relentless drive to solve real problems xe2x80x93 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, wexe2x80x99ve 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.

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About Worldwide Research and Development

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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.

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The Medical Writer 1 applies basic to intermediate 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.

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Responsibilities

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• 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 n
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigatorxe2x80x99s brochures and periodic safety reports (PBRERs, DSURs, etc.) n
• Aids in managing 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 n
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials n
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. n
• Assists in developing and reviewing standard processes and templates within Global Medical Writing n
• Works effectively with cross-functional groups within BioMarin n
• Other tasks as assigned. n

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Scope

nnnnnThis position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase 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.nnnn

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Education

nnnnBachelorxe2x80x99s or higher degree preferred; scientific focus desirable.n

Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.

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Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.nnnn

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Experience

nnnnRelevant Experience

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nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Up to 2 years as a medical writer in the pharmaceutical industry

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 At least 5 years of medical or scientific writing experience as a primary job responsibilityn

Clinical Studies

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Familiar with drug development process (discovery to market).

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Basic understanding of biostatistical and clinical research concepts.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Basic applied knowledge of:

noxc2xa0xc2xa0 documentation required for the conduct of clinical studies

noxc2xa0xc2xa0 protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)

noxc2xa0xc2xa0 study results reporting

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Medical Writing

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Writing high-quality documents that support corporate goals and objectives.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Experience writing, reviewing, or editing protocols and clinical study reports preferred.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Basic 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.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to interpret basic tabular and graphical clinical data presentations.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to create basic tables using AMA style (eg, Schedule of Events).

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Basic to intermediate applied knowledge of basic clinical laboratory tests.

nxc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

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Computer/office equipment Skills

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• Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint. n
• Familiar with document management software (eg, LiveLink, SharePoint, Veeva) n
• Experienced with scanners, printers, and copiers. n

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Regulatory

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• Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports). n

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Project Management

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• Capable of working on multiple tasks and shifting priorities. n
• Good conflict management skills. n
• Motivated and shows initiative. n
• Detail oriented. n

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Communication

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• Capable of well organized, concise and clear written and verbal communication. n
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. n
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. n

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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.

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Equal Opportunity Employer/Veterans/Disabled

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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.

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The salary range for this position is: $74,100 to $100,000. 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.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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