Principal Medical Writer (Regulatory Writing)

job summary: Principal Medical Writer | Flex / Contract Long Term Contract (1 year to start) Rate: $110-$125 PH This is a Flex/Contract Regulatory Medical Writing position. You will need to have significant experience as primary offer for a wide range of document types including CSRs, Protocols, IBs, etc. across a variety 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 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.

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 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 complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas
• Ability to adapt and work through conflicts to create consensus
• Proficiency in Microsoft Office applications
• Familiarity with CTD, ICH, GCP and other standards
• Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment

Benefits

• Medical, Dental, and Vision 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, 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 [email protected]. 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. Apply tot his job Apply To this Job