Principal Medical Writer – Nonclinical Focus
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Job Description
Principal Medical Writer preparing regulatory documents supporting all product development phases. Collaborating with teams and leading document preparation while ensuring compliance with regulatory standards.
Responsibilities:
- The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
- 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.
- 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.
Requirements:
- 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 preparation, document review, accurate comment resolution/incorporation, and document finalization
- Ability to own submission-level sections (e.g., nonclinical section [Module 2.6]), 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
- Develop professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
- Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance
- Ability to resolve problems that arise, 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 strength the skill base across the organization.
Benefits:
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
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