Medical Writer II
The Quality department resides organizationally within Regulatory Documentation and Submissions (RDS) and provides various services including, but not limited to: quality reviews (data/content verification and consistency, style application, editing), audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications.
Responsibilities of the Senior Associate, RDS Quality, include the following:
•Perform high-quality reviews of regulatory deliverables
•Function as the RDS Quality Lead for various regulatory deliverables
•Assist in audit preparation
•Support RDS Quality initiatives
•Act as a departmental RDS Quality resource
•Performs detailed and thorough quality reviews to ensure data integrity, internal content consistency, completeness on a wide range of regulatory deliverables (CSRs, IB/Updates, CTDs, PK/Pop PK reports, etc) in accordance with RDS Quality standards and tools.
•Performs editorial reviews to ensure style is consistent with the R & D Manual of Style and within regulatory deliverable.
•Serves at the primary RDS Quality point-of-contact for assigned deliverables, monitors timelines, communicates with Lead Writer to ensure review expectations are understood and met, and alerts Lead Writer in a timely manner if deliverable is at risk.
•Participates in RDS Quality team meetings presenting timelines and updates of assigned deliverables alerting team of any potential resourcing issues.
Advises on deliverable review strategies.
•Able to forecast individual project workload and proactively identify and communicate potential workload peaks.
•Closely collaborates with Audit SME and Lead Writer to support audit preparation by gathering documents and performing quality review to ensure audit package is complete and accurate.
•Assists with the development and delivery of relevant training and new hire o on boarding programs.
•Participates in development and/or revision of internal policies and procedures impacting quality standards and tools.
•Contributes to the development and maintenance of applicable standard operating procedures, manuals, and work practices.
•Responds to general Quality questions, helps train writers on review process and expectations, and remains current with industry Quality standards.
•Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate.
•Has developed organizational skills; is detail oriented; and able to work in a fast paced, deadline-driven environment.
•Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.
•Familiar with AMA Manual of Style.
•Has excellent verbal and written communication skills and interpersonal skills.
•Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management.
•Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and a Regulatory Document Management System.
•A BS degree
•A minimum of 4+ years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, including a minimum of 2 or more years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions.
•Ideal candidates include those who are familiar with Phase 1 to 3 clinical protocols and study reports and understand the drug development process leading to marketing applications
Has well developed computer skills including proficiency in Word, Adobe and Excel.