WebbWrites LLC is a boutique medical writing and statistics firm, specializing in strategic regulatory writing for drugs, biologics, and devices. Our experienced team, primarily based in Durham, North Carolina, partners with biotechnology and pharmaceutical clients to collaboratively produce high-quality protocols, clinical study reports, and integrated clinical summary documents. Our streamlined workflows propel our clients to successful regulatory submissions, advancing the mission to bring safe, life-changing therapies to patients around the globe.
Learn more about WebbWrites: https://webbwrites.com/
Under the guidance of a mentor, the medical writer will contribute to, independently prepare, and QC clinical regulatory documents, including CSRs, protocols, and integrated clinical summary documents (eg, ISE/ISS, CTD Module 2 Sections 2.7.3, 2.7.4, 2.5, and Investigator Brochure’s), for biotechnology and pharmaceutical clients. This position is largely remote, however, ability to occasionally commute into our office in Durham, NC is strongly preferred.
Responsibilities and Qualifications
• Perform independent QC of CSRs, narratives, protocols, integrated clinical summary documents.
• Independently author CSRs, narratives, and protocols.
• Contribute to authoring of clinical summary documents.
• Critically analyze and interpret clinical disposition, demographic, efficacy, and safety data for writing and QC functions.
• Collaborate with internal team members to prioritize upcoming work and maintain client timelines.
• Participate in monthly training seminars with the whole WebbWrites team as well as other continuing education opportunities
• Develop and maintain working knowledge of ICH guidelines, for example ICH E3 (CSRs), ICH E6(R2) (Good Clinical Practice), ICH M4E(R2) (The CTD).
• Bachelor’s degree in life science
• At least 2 years of relevant work or research experience
• Ability to understand and interpret data
• Strong written and verbal communication skills
• Detail oriented, organized, high regard for quality
• Demonstrated ability to work on a team
• Proficiency in MS Office (Word, Excel, Outlook, PowerPoint)
• Experience with or willingness to learn other software, such as SharePoint, Asana, EndNote, and PleaseReview
Please email resume and cover letter to firstname.lastname@example.org