Contract Medical Writer - Nonclinical Writing

Nonclinical pharmacology and toxicology focused. Must have 5 years of recent medical writing experience in the pharma or biotech industry.

Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents)
Collaborate closely with client, internal, and partner organization teams to devise strategies for organizing and preparing regulatory documents.
Take charge of a project team and actively engage in the development and writing of high-quality documents, encompassing study-level and submission-level documents, as well as pharmacovigilance documents.
Generate documents in accordance with client specifications, templates, style guides, and other guidance documents.
Author documents adhering to regulatory authority guidelines and requirements.
Serve as a trusted client advisor, fostering collaborative relationships through consistent and reliable communication, and effectively conveying ideas and strategies for successful outcomes.
Practice blameless problem-solving, adopting a broad perspective to resolve issues and prevent adverse impacts on work.
Manage the budget for low-complexity projects, overseeing all contributors, including writers and editors.
Guide documents through the review process, conduct comment resolution meetings (CRMs), and lead project teams to consensus successfully.
Sustain collaborative, proactive, and effective communication with both client and internal teams.
Lead meetings and teleconferences related to the project.
Provide coaching to junior staff for study-level and submission-level documents, ensuring compliance with company standard operating procedures (SOPs) and training requirements.