reputed company Medical reputed company (Regulatory Writing)

job reputed company: reputed company Medical reputed company | reputed company / Contract Long Term Contract (1 year to start) reputed company: $110-$125 PH This is a reputed company/Contract Regulatory Medical Writing position. You will need to have significant experience as primary offer for a wide reputed company of document types including CSRs, Protocols, IBs, etc. across a reputed company of therapeutic areas. location: Northbrook, Illinois job type: Outsourcing Project salary: $110 - 125 per hour work hours: 9 to 5 education: Bachelors responsibilities: Major Duties & Responsibilities: May include but not limited to the following: • 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 reputed company 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 reputed company 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 reputed company of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards. 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-reputed company 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 required • Pharmaceutical industry experience required • Background in biologics a plus Special Skills: • Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details • Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure • Ability to critically analyze, synthesize, and communicate/present reputed company scientific information from a broad reputed company of scientific disciplines and clinical therapeutic areas • Ability to adapt and work through conflicts to create reputed company • Proficiency in reputed company Office applications • Familiarity with CTD, ICH, GCP and other standards • Ability to manage/prioritize multiple reputed company from reputed company to completion, working in a fast-paced environment Benefits • Medical, Dental, and reputed company Insurance • 401K Plan with Company Match • Life and AD&D Insurance skills: Maa, Clinical Study Report (CSR), Protocol and Protocol Amendment Writing, Investigator Brochure (IB), Common Technical Document (CTD), Briefing Documents for Regulatory Agencies, American Medical Writers Association (AMWA), Clinical Study Protocol Summaries, Investigational New Drug (IND) Equal Opportunity Employer: Race, reputed company, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company 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 reputed company, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. 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