MEDICAL reputed company (TEMPORARY)

LOCATION SAN RAFAEL, CALIFORNIA Who We Are BioMarin is a global biotechnology company that relentlessly pursues reputed company science to translate genetic discoveries into new medicines that advance the reputed company of reputed company health. Since our founding in 1997, we have reputed company 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 reputed company medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a reputed company drive to solve reputed company problems – and create an environment that empowers our teams to pursue reputed company, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of reputed company, clinical and preclinical candidates that have reputed company-reputed company biology and reputed company an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic reputed company. About reputed company and Development From research and discovery to post-market clinical development, our WWRD reputed company involves reputed company bench and clinical research and the associated reputed company that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that reputed company meaningful advances to patients who live with genetic diseases. Note: This reputed company is not intended to be reputed company-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. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. HYBRID (1-2 DAYS IN OFFICE TO reputed company WITH COMPANY POLICY). Seeking candidates who are regulatory medical writers (not Medical Communication) The Contract Medical reputed company 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 for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
• 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
• Adheres to departmental procedures and practices and technical and industry standards during reputed company aspects of work.
• Works effectively with cross-functional reputed company reputed company BioMarin  Other tasks as assigned.
• SUPERVISOR RESPONSIBILITYNone.

CONTACTS Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, reputed company, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance. EQUIPMENT reputed company to corporate computer network, production computing environment, and MS reputed company software. Skills Fulfills one of the following:

• Medical reputed company in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility

reputed company AND EXPERIENCE: AT LEAST 5 YEARS EXPERIENCE REQUIRED

• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.  Previous protocol development experience required.
• Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
• Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
• Intermediate to advanced reputed company knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced reputed company knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Ability to create basic tables using AMA style (eg, Schedule of Events).
• Intermediate reputed company knowledge of basic clinical laboratory tests.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Basic understanding of biostatistical and clinical research concepts.Proficient in reputed company Word (including the use of templates), reputed company, and PowerPoint.
• reputed company with scanners, printers, and copiers.Basic knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• 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.Good conflict management skills.Motivated and shows initiative.
• Detail oriented.Capable of reputed company organized, concise and reputed company written and verbal communication.Capable of comprehending reputed company scientific concepts and translating them into reputed company, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

Education

• Bachelor’s or higher degree; scientific reputed company desirable.
• Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, reputed company in Life Sciences certificate, or relevant training through Drug Information Association.

In the U.S, the salary reputed company for this position is $ reputed company to $ reputed company per hour. The reputed company pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-reputed company knowledge, skills, and experience amongst other factors. The salary reputed company for this position is: $reputed company to $reputed company. BioMarin considers a reputed company of factors reputed company determining reputed company 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), reputed company time off, and a benefits package. Benefits include company-sponsored medical, dental, reputed company, 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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