Job Description

Join to apply for the Medical Writer role at BioSpace Hybrid (1-2 days in office to align with company policy). 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. 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. About BioMarin / Worldwide Research And Development 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. From research and discovery to post-market clinical development, our Worldwide Research And Development (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. 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. 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 all aspects of work. Works effectively with cross-functional groups within BioMarin and other tasks as assigned. Supervisory responsibility: None. Contacts include Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance. Access to corporate computer network, production computing environment, and MS Windows software. Skills & Experience Fulfills one of the following: Medical writer in the pharmaceutical industry; medical or scientific writing experience as a primary job responsibility. Minimum 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 is highly preferred. Experience writing, reviewing, or editing INDs and BLA/NDAs is highly preferred. Advanced 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 (e.g., Schedule of Events). Understanding of basic clinical laboratory tests; basic understanding of coding dictionaries (MedDRA, WHO Drug). Proficient in Microsoft Word (templates), Excel, and PowerPoint. Experience with regulatory requirements and guidances related to standalone regulatory documents (protocols, investigator brochures, clinical study reports). Ability to manage multiple tasks and shifting priorities; capable of leading a cross-functional team under strict timelines, including leading meetings and document review processes. Strong written and verbal communication, detail-oriented, organized, and able to translate complex scientific concepts into clear, regulatory-compliant text. Basic presentation skills; ability to explain writing principles to varied audiences. Education Bachelor’s or higher degree; scientific focus desirable. Evidence of medical writing career development desirable (e.g., relevant certificates). Seniority level Mid-Senior level Employment type Full-time Job function Marketing, Public Relations, and Writing/Editing Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x #J-18808-Ljbffr BioSpace

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