Sr. Medical Writer Job at TALENT Software Services in California

Job Summary Talent Software Services is in search of a Sr. Medical Writer for a contract position in CA (Remote). The opportunity will be six months with a strong chance for a long-term extension. Position Summary This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full‑time employee will enable Client to reduce writing‑related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. Primary Responsibilities Draft and edit documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Draft and edit documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.) Draft and edit documents used in the preparation of regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries) Manage 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 Represent Global Medical Writing at cross‑functional team meetings (e.g., study team, development team, other subteams) Build effective partnerships with cross‑functional groups to ensure customer/stakeholder needs are met Provide peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Assist 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 Adhere to departmental procedures and practices and technical and industry standards during all aspects of work Work effectively with cross‑functional groups within Client's Other tasks as assigned Qualifications 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 Up to 6 years 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 experience 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, protocol design, study results reporting, integrated results reporting, and direct experience with documentation in all phases of drug development Experience writing, reviewing, or editing protocols and clinical study reports 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 coding dictionaries (MedDRA, WHO Drug) Proficient in Microsoft Word, Excel, Adobe Acrobat, MS Project, and PowerPoint Experience using document management software (e.g., LiveLink, SharePoint, Veeva) Experience with scanners, printers, and copiers Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (e.g., protocols, investigator brochures, and clinical study reports) 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 team review and comment adjudication stages of document preparation Capable of representing Global Medical Writing at cross‑functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross‑functional conflicts Good conflict management skills Motivated and shows initiative Detail oriented Capable of well organized, concise and clear written and verbal communication Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills Apply Now If this job is a match for your background, we would be honoured to receive your application! Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk! #J-18808-Ljbffr