Principal Medical Writer - CMC Focus

Principal Medical Writer - CMC Focus page is loaded## Principal Medical Writer - CMC Focus remote type:
Fully Remote locations:
Massachusetts:
Canada:
United Statestime type:
Full time posted on:
Posted Yesterday job requisition : R
- *
* Job Description:

**** Job Overview:
** 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.
** Make an Impact at Veristat!
** Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
* 105+ approved therapies for marketing applications prepared by Veristat
* 480+ oncology projects in the past 5 years
* 350+ rare disease projects delivered in the past 5 years
* Flexible, inclusive culture - 70% remote workforce, 66% women-led teams

Learn more about our core values !
*
* What we offer:

*** The estimated hiring range for this role is $132K to $151K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
* Benefits vary by location and may include:* + Remote working* + Flexible time off* + Paid holidays* + Medical insurance* + Tuition reimbursement* + Retirement plans
** What we look for:
**** Education, Experience, Training, and Knowledge:
*** 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
* Ability to lead a project team
* 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
** Skills & Abilities:
*** 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
* Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization
* Ability to 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
* Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
* Demonstrate solid time management and other organizational skills
* Ability to develop professional relationships…