Principal Medical Writer - Clinical Focus

Job Description:

Position specific overview

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.

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 here!

What we offer

·         The estimated hiring range for this role is $132K to $151Kplus 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:

o   Remote working

o   Flexible time off

o   Paid holidays

o   Medical insurance

o   Tuition reimbursement

o   Retirement plans

What we look for

Education, Experience, Training, and Knowledge:

• 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

Skills & Abilities:

• Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Able to 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
• Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
• Ability to lead 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
• Ability to lead 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
• Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
• Ability to 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

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.