Sr. Regulatory Writer

Less than 5 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Raleigh, NC
Less than 5 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

Position Overview

Responsibilities

  • Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer, depending on document type or therapeutic experience

  • Author documents per client specifications, templates, style guides, and other guidance documents

  • Author documents per regulatory authority guidelines and requirements

  • Act as a client point of contact

  • Manage budget for respective project or task within a project

  • Usher documents through the review process, conduct comment resolutions meetings (CRMs)

  • Maintain collaborative, proactive, and effective communication with both client and internal teams

  • Lead or participate in project-related meetings and teleconferences

 

Reporting Structure

  • Senior Regulatory Writers report to a Team Lead

  • Team Leads report directly to the CEO

 

Experience Required

 

  • Experience writing study-level documents in their entirety and the ability to lead/own a study-level document

  • Collective experience writing a range of study-level documents for various clients:

    o Investigator’s Brochure

    o Protocol

    o Clinical Study Report – abbreviated and synoptic

    o Pharmacokinetic Reports

    o QT Studies

    o Observational and Non-interventional Reports

  • Experience in the development of submission-level documents (does not require functioning as a document lead):

    o Briefing Packages

    o IND/CTA/IMPD

    o NDA/BLA/MAA/NDS

 

Skill Requirements

 

  • BS/BA

  • 3-5+ years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety related documentation

  • Strong understanding of the document creation process and of clinical development and study level clinical operations from conceptual study design to final CSR/CTR

  • Ability to analyze clinical data and present it in a written format

  • Ability to conduct/lead a CRM and successfully lead a project team to consensus

  • Ability to provide high-quality customer service and follow-through on all assignments

  • Excellent Microsoft Word skills and document management techniques

  • Professional, personable demeanor

  • Strong interest in a writing/editing role

 

The Ideal Candidate

  • Is a team player who enjoys collaboration

  • Desires challenges, both technical and interpersonal

  • Is flexible with an extremely high level of attention to detail

Opportunity and Value for the Right Candidate

  • Variety— submission-level work across therapeutic areas

  • Flexibility — custom schedules and benefits of “flex time”

  • Stability — almost 30 years in business

  • Support — a community of writers working as a team

  • Excellent potential for growth and advancement

    ID1068

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