- Title: Medical Writer
- Code: RCI-9326
- Location: Foster City California (CA) 94404
- Posted Date: 01/13/2021
- Duration: 17 Months
- Name:Mangesh Kanade
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 260
****This job is for Sr Quality Review Specialist, Regulatory Documentation and Submissions (RDS).
- The Quality department resides organizationally within Regulatory Documentation and Submissions (RDS) at Client`s 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 Sr. Quality Review Specialist, RDS Quality, include the following:
- Performs detailed and thorough quality reviews to ensure data integrity, internal content consistency, completeness on a wide range of regulatory deliverables (CSRs, IBs/IB updates, CTDs, PK/Pop PK reports, etc.) in accordance with Client`s RDS Quality standards and tools.
- Performs editorial reviews to ensure style is consistent with the R & D Manual of Style and within regulatory deliverable.
- Able to forecast individual project workload and proactively identify and communicate potential workload peaks.
- Advises on deliverable review strategies as needed.
- Assist Audit subject matter expert and Lead Writer with audit preparation. Tasks include gathering documents and performing quality review to ensure audit package is complete and accurate.
- 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.
- Assists with the development and delivery of relevant training and new hire on boarding programs as needed.
- Participates in development, maintenance, and/or revision of internal policies and procedures impacting RDS quality standards and tools as needed.
- Supports RDS Quality initiatives as needed.
- Participates in RDS Quality team meetings.
- Responds to general Quality questions, helps train writers on review process and expectations, and remains current with Client`s and 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.
- 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.