Principal medical writer (regulatory writing) Job at Randstad in Whitehouse Stat

job summary:
Principal Medical Writer (Regulatory Writing)

Salaried w/Full Benefits (range: $160-$190K)

Remote

Randstad Life Sciences is seeking a Principal 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.

location: Telecommute
job type: Outsourcing Project
salary: $85 - 95 per hour
work hours: 9 to 5
education: Doctorate

responsibilities:
Major Duties and Responsibilities (including supervising others)

• Under minimal or no supervision, writes and edits clinical study reports, protocols, informed consent forms, and other clinical and regulatory documents including Investigator Brochures and annual reports
• Leads the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed
• Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts
• Negotiates timeline development for preparation of clinical regulatory documents
• Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents)
• Reviews case report forms, statistical analysis plans, and data tables and listings for content and format
• Assists in or leads the preparation or revision of SOPs, WPDs, and document templates
• Participates in clinical project team meetings
• Participates in or leads other cross-functional team meetings and standards committees
• Provides mentoring to junior writers
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards

Special Skills/Abilities:

• Experience writing and editing clinical regulatory documents
• Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas
• Excellent writing, editing, attention to detail, and verbal communication skills
• Proficiency in Microsoft Word is essential
• Familiarity with CTD, ICH, GCP, and other standards
• Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment

qualifications:
Education

• Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience

Experience

• Minimum 6 years' experience writing clinical regulatory documents including clinical study reports
• Pharmaceutical industry experience required
• Background in biologics a plus

#LI-AT1

skills: Maa, 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), Clinical Study Protocol Summaries

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.