Principal Medical Writer - Clinical Focus

Veristat•Massachusetts, MA

43d•$132,000 - $151,000•Remote

About The Position

Medical Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Principal Medical Writer (PMW) is a major contributor to document authorship for a variety of documents across different service lines. The PMW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

Requirements

Bachelor’s degree (minimum)
7+ years of regulatory writing experience with clinical- related documentation
Understands regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
Strong understanding of the document creation process and of the drug development lifecycle
Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques

Responsibilities

Project leader and authoring contributor for all types of client engagements.
Mentoring others in the knowledge of authoring regulatory documents.
Leading submission-level sections (clinical documents, e.g., Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE) taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects.
Leading sub-teams for deliverables (e.g., pharmacovigilance documents, transparency & disclosure deliverables), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects.
Synthesize data across multiple data sources and documents to create summary reports.
Practice blameless problem solving, effectively managing all crisis communications, managing risks, and realizing business opportunities.
Communicate difficult and complex ideas clearly and effectively to all stakeholders.
Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making.
Identify potential problems, promptly tackling those problems, particularly in sensitive or high-pressure situations.
Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.