Principal Medical Writer - CMC Focus

Veristat•Massachusetts, MA

13d•$132,000 - $151,000•Remote

About The Position

Regulatory Writers prepare high‑quality documentation for regulatory submissions 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 or higher, scientific discipline strongly preferred
7+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation
Experience in areas such as vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability
Experience with submissions such as NDAs, INDs, BLAs, or IMPDs
Experience authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3
Understanding of regulatory authority guidelines and requirements and to anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval and acceptance
Understand regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Experience as a document lead in the development of submission-level documents
Intermediate proficiency with Microsoft Word skills (editing tools, creating, and modifying tables, and inserting figures) and document management techniques
Strong understanding of the document creation process and of the drug development lifecycle
Ability to synthesize data across multiple data sources and documents to create summary reports
Ability to develop professional relationships with clients as to further the business relationship and maintain current industry knowledge
Ability to resolve problems that arise, particularly in sensitive or high-pressure situations

Nice To Haves

Mentoring others in the knowledge of authoring regulatory documents.
Ability to lead a project team.
Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making.
Demonstrate solid time management and other organizational skills.
Maintain current industry knowledge.
Integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.

Responsibilities

Prepare high-quality documentation for regulatory submissions.
Act as a project leader and authoring contributor for client engagements.
Mentor others in the knowledge of authoring regulatory documents.
Lead a project team.
Provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization.
Own submission-level documents (e.g., Module 3), taking responsibility for clarity of purpose, leading others toward the common goal within the timeline and budget on complex projects.
Develop professional relationships with clients.
Identify and institutionalize work practices that are most effective in ensuring consistency in performance.
Resolve problems that arise, particularly in sensitive or high-pressure situations.
Transfer knowledge to strengthen the skill base across the organization.