Senior Regulatory Medical Writer, Client-embedded, FSP

Overview

Remote Senior Medical Writer within the FSP team, authoring clinical and regulatory documents and supporting clients from planning through final drafts.

What you'll do

• Serve as primary author for routine clinical documents such as clinical study reports and study protocols, and summarize data from clinical studies.
• Serve as primary author for complex clinical, scientific and program-level documents, such as IBs, bioassay reports, INDs and MAAs.
• Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.
• Ensure documents align with regulatory guidelines, company standards and industry best practices.
• Provide input on document content, structure and presentation.
• Review and provide feedback on documents prepared by other team members.
• Manage timelines and deliverables for assigned projects.
• Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
• Stay current with industry trends, guidelines and regulatory requirements.

What you'll need

• Bachelor's degree in a scientific discipline or equivalent, and relevant formal academic or vocational qualification, or an equivalency of appropriate education, training and/or directly related experience.
• Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 5+ years).
• Proven track record in authoring clinical regulatory documents.
• Excellent data interpretation and medical writing skills, including grammatical, editorial and proofreading skills.
• Strong project management skills.
• Excellent interpersonal skills, including problem solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national and other document development guidelines.
• Great judgment and decision-making skills.
• Excellent computer skills and skilled with client templates; good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).

Nice to have

• Advanced degree.
• Experience working in the pharmaceutical/CRO industry.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous.
• Versatility to author and support preclinical regulatory documents as part of a broader regulatory writing portfolio.

Details

• Remote, based in the US.
• First shift (days).