Remote Sr. Medical Writer Job at Planet Pharma in San Rafael

Overview Join to apply for the Remote Sr. Medical Writer role at Planet Pharma Responsibilities Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.) Drafts and edits documents used in the preparation of regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries) Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other subteams) Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments Adheres to departmental procedures and practices and technical and industry standards during all aspects of work Works effectively with cross-functional groups Other tasks as assigned Education Bachelor’s or higher degree required; scientific focus desirable Minimum requirement: Experience in medical writing Evidence of medical writing career development desirable, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association Experience Fulfills One Of The Following Up to 6 years of as a medical writer in the pharmaceutical industry At least 10 years of medical or scientific writing experience as a primary job responsibility Clinical Studies Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection Intermediate to advanced applied knowledge of documentation required for the conduct of clinical studies and protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) Direct experience with documentation in all phases of drug development Medical Writing Experience writing, reviewing, or editing protocols and clinical study reports required Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred Experience writing, reviewing, or editing regulatory briefing books preferred Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content Ability to interpret and create complex tabular and graphical clinical data presentations Advanced applied knowledge of basic clinical laboratory tests Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug) Computer/Office Equipment & Regulatory Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint Experience using document management software (e.g., LiveLink, SharePoint, Veeva) Experience with scanners, printers, and copiers Regulatory: Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports) Prior familiarity with standard ECTD IND/NDA work, including Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format; Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Project Management & Skills Capable of working on multiple tasks and shifting priorities Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing review and comment adjudication stages Capable of representing Global Medical Writing at cross-functional meetings and resolving cross-functional conflicts Good conflict management skills; motivated, initiative, detail-oriented Capable of well-organized, concise and clear written and verbal communication; ability to translate complex scientific concepts into clear, regulatory-compliant text; capable of intermediate to advanced presentation skills The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Notes Salary ranges and postings shown are indicative and may be subject to change. This description preserves original content and context without adding new facts. #J-18808-Ljbffr