Job Description

A highly reputable and distinguished pharmaceutical corporation is currently hiring a qualified Medical Writer - Level II to work in the greater San Francisco, CA. bay area.

• Medical Writer - Level II working within the Medical Writing & Regulatory Documentation and Submissions (RDS) Group focused on 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 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 onboarding 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 company 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.
• 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.
• Effectively communicate with a variety of teams and individuals, including team leadership and members of senior management.
• Capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and a Regulatory Document Management System.

Typically requires:

• Bachelors of Science 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
• Developed computer skills including proficiency in Microsoft Excel, Word, Adobe
• Excellent verbal and written communication skills and interpersonal skills.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.