Remote Medical Writer wanted (non-clinical writing) | $90 to $120 per hour
Added 2024-01-11 20:00:18 +0000 UTCCOMPANY/PUBLICATION: THOR COMPANIES
Responsibilities: 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.
CONTACT INFORMATION:
Original job posting: Click here
Website: https://www.thor-companies.com/
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