Principal Medical Writer-nonclinical focus

Job Description

Key

Purpose:

The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents. Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents). Author documents per client specifications, templates, style guides, and other guidance documents. Author documents per regulatory authority guidelines and requirements.

Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result. Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work. Manage budget for a low complexity project, including all contributors (writers, editors). Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus.

Maintain collaborative, proactive, and effective communication with both clients and internal teams. Lead project-related meetings and teleconferences. Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.

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!

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

Bachelor’s degree; MS or PhD preferred 7+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD such as: 2.4 Nonclinical Overview 2.6 Nonclinical Summaries Pharmacology or Toxicology Reports ADME Reports

Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance

Experience in the development of submission-level documents (does not require functioning as a document lead)

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 Able to synthesize data across multiple data sources and documents to create summary reports Expertise to provide subject matter guidance for quality document…