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Senior Manager Medical Writer

Company: Systems Technology International
Location: Novato
Posted on: September 16, 2020

Job Description:

Systems Technology International, Inc. (STI), a full service innovative professional services corporation serving in virtually every industry. STI offers professional services in the Technical/Engineering, IT (Information Technology), Creative and marketing, Business Analyst, Accounting and office support areas.. Job Description. Senior Manager Medical WriterCompany Work Location: Novato, CADomain: Health Care. Candidates must have Green card or US Citizens ONLY. Job Description:. Experienced Senior Manager Medical Writer is required having responsible for writing and overseeing the writing of various clinical and regulatory documents and peer-reviewed scientific publications, including distribution of work to contract medical writers as needed.. Responsibility:. • Write, manage or oversee the writing of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)• Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses.• Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) • Distill large amounts of clinical and scientific data into essential elements for graphical display• Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams. Required Skills:. • BS, MS, or doctorate in a scientific or medical field • Eight+ years in the biotechnology/pharmaceutical industry preferred• Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.• Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices• Proven ability to develop and implement medical writing processes and standards• Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues• Flexible; adapts work style to meet organization needs• Strong organizational abilities and experience in a multitasking environment• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals• Rare disease experience and a strong understanding of metabolic genetics a plus. (FOR FASTER PROCESS: Just go to Google and Search "STI JOBS" you will see the website in the top listing. Go through the website and search the Job in the search box. Apply Directly through the website. ). Additional Information. (FOR FASTER PROCESS: Just go to Google and Search "STI JOBS" you will see the website in the top listing. Go through the website and search the Job in the search box. Apply Directly through the website)

Keywords: Systems Technology International, Novato , Senior Manager Medical Writer, Other , Novato, California

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