Principal / AD, Medical Writer

Reference: 629950Posted: 2026-09-03Location: Boston, MassachusettsCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on job-api.jobget.com Writing Contractor, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according standards.Key Accountabilities/Responsibilities:The position will have the following key responsibilities: Support the clinical medical writing team, in developing content for a variety of clinical regulatory documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), safety narratives, and eCTD modulesDraft and manage documents that are well-organized, accurate, consistent, and comply with applicable company SOPs and regulationsEnsures all clinical documents are standardized according to the style guide and are based on company-approved document templates to ensure quality and consistency of the portfolioPartner with Quality Assurance (QA) during an audit of clinical trial documents to ensure timely response to findingsCollaborate with members of clinical trial teams and other functions within medical writing to ensure project deadlines are met by providing content development support, research, and editing functions for each programDesired Skills and Experience:Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferredNative English speaker preferredMinimum of 5-7 years of pharmaceutical/biotechnology-related medical writing experience requiredKnowledge of all FDA and ICH guidelines for clinical reporting requiredeCTD development, publishing, and submission experience preferredBiologic writing experience preferredBasic understanding of drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submissionAbility to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)Ability to proofread documents for compliance with internal and external guidance documentsAbility to approach issues from various perspectives and accurately summarize data to draw a conclusionAbility to work precisely according to procedures and regulationsExcellent written and verbal communication skillsAbility to prioritize and multi-task successfully in a fast-paced environmentAbility to work autonomously, as well as in a teamExcellent time management skills and a proven ability to work on multiple projects at any given timeMust be proficient in MS OfficeExperience in electronic publishing format preferred