job summary: Sr. Medical Writer (Clinical/Regulatory) Salaried w/Full Benefits $165K-$180K | REMOTE Randstad Life Sciences is seeking a Senior Medical Writer to join our internal Medical Writing Program, supporting a leading global pharmaceutical partner. This position offers a unique opportunity to contribute to a high-performing, long-term program dedicated to a single client partnership. Major Duties and Responsibilities: Works independently to write and edit clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas as assigned. Works with contract writers as needed for the timely delivery of assigned documents.Reviews clinical protocols, Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed.Assists with the preparation of briefing documents, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed.Demonstrates critical thinking in the analysis and presentation of clinical study data.Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.Provides QC support for clinical regulatory documents as needed.Assists with the preparation or revision of SOPs, WPDs, and document templates. Assists with training across functional areas for the implementation of new/revised procedures and templates.Participates in Clinical Trial Team meetings and other cross-functional team meetings.Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards. location: Northbrook, Illinois job type: Outsourcing Project salary: $77 - 85 per hour work hours: 9 to 5 education: Bachelors responsibilities: Special Skills Required: Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to detailsExperience writing and editing ICH-compliant clinical regulatory documents according to CTD structureAbility to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas Ability to adapt and work through conflicts to create consensusProficiency in Microsoft Office applicationsFamiliarity with CTD, ICH, GCP and other standardsAbility to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment qualifications: Qualifications Education Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience. MS or PhD in biological science preferred. Experience 6 + years experience writing high-quality clinical regulatory documents including clinical study reports across multiple therapeutic areas. Experience writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions requiredPharmaceutical industry experience requiredBackground in biologics a plus skills: Maa, GCP (Good Clinical Practice), Clinical Study Report (CSR), Protocol and Protocol Amendment Writing, Investigator Brochure (IB), Informed Consent Form (ICF), Regulatory Submission Writing, Common Technical Document (CTD), Briefing Documents for Regulatory Agencies, American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), Investigational New Drug (IND), International Council for Harmonization (ICH) 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.