22 days old

Sr. Quality Review Specialist - Medical Writer

Kelly Services
Foster City, CA 94404
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Sr. Quality Review Specialist - Regulatory Documentation and Submissions** at a prestigious Fortune 500 company working in **Foster City.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Sr. Quality Review Specialist - Regulatory Documentation and Submissions**

**Pay: $60 - 73 per hour depending on experience**

***Remote work is considered if the candidate is proven and successfully worked remotely before**


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.

**Requirements** :

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

Well developed computer skills including proficiency in Word, Adobe and Excel.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **** **?**

Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2020-07-13 Expires: 2020-08-13

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Sr. Quality Review Specialist - Medical Writer

Kelly Services
Foster City, CA 94404

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