Join to apply for the Senior Medical Writer role at Randstad Life Sciences US 1 day ago Be among the first 25 applicants Join to apply for the Senior Medical Writer role at Randstad Life Sciences US Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Randstad Life Sciences US Life Science & Clinical Recruiting Director | Talent Acquisition | Recruiting & Sales Operations | Team Engagement | Passion for people and for… Job Summary The Contract Medical Writer 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. Schedule / Shift: 1st shift, Mon-Fri; Hybrid (1-2 days in office) location: San Rafael, California job type: Contract salary: $68.00 - 70.94 per hour work hours: 9 to 5 education: Bachelors 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 the company Other tasks as assigned. Qualifications Medical writer in the pharmaceutical industry Medical or scientific writing experience as a primary job responsibility At least 6+ 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 applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied 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 applied 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 Microsoft Word (including the use of templates), Excel, and PowerPoint. Experienced with scanners, printers, and copiers. Basic knowledge of regulatory requirements and guidance 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 well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, 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 focus desirable. Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. skills: NDA, Psur, GCP (Good Clinical Practice), Medical Information, CTD Structure, DSUR Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. u9000030197 Seniority level Seniority level Not Applicable Employment type Employment type Contract Job function Job function Science, Writing/Editing, and Research Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Randstad Life Sciences US by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Senior Medical Writer” roles. 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