Associate Principal Regulatory Writer

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Raleigh, NC
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

 Corporate Culture

Synchrogenix was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual—regardless of experience level—has something to teach and something to learn.

 Synchrogenix has built its culture on:

  • Being fast and flexible, non-hierarchical, apolitical, and non-defensive
  • Active participation—nobody sits on the sidelines
  • Teamwork—the company’s success is important to all of us
  • Cross-functional communication (lots of it) and a high-tech culture that works to have everyone on the same page
  • Disciplined leadership that inspires passion and commitment
  • Personal accountability
  • Strong peer and management support for those who want to learn
  • A calm and professional workplace—no drama!

Position Overview

Responsibilities

  •  Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents

  • As part of project teams, actively participate in development and writing of high-quality documents, such as CSRs, briefing books, and clinical summaries

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

  • Author documents per regulatory authority guidelines and requirements

  • Manage overall budget for respective project, including all contributing writers and editors

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

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

  • Lead project-related meetings and teleconferences

  • Provide training of writing staff and ensure compliance with company standard operating procedures (SOPs) and staff training requirements

  • Adhere to SOPs for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization

 

Reporting Structure

  • Associate Principal Regulatory Writers report to a Team Lead

  • Team Leads report directly to the Director of Team Leads

 

Skill Requirements

  • BA/BS

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

  • Ability to synthesize data and present it in a written format

  • Shown success in Word skills and document management techniques

  • Understanding of document creation process and ability to lead/own a study level document

  • Collective experience writing a range of study-level documents in their entirety and able to lead/own a study level document

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

  • Understanding of regulatory requirements for different phases of development and different regulatory pathways and knowledge of global health authority requirements

  • Has led the development of one or some types of submission-level documents within the CTD

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

  • Professional, personable demeanor

     

    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

    ID1040

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