Associate Medical Writer.
Job Description
- Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
- Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
- Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
- Critically assesses, interprets, and summarizes data from clinical studies
- Reviews scientific literature pertinent to medical writing activities
- Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
- Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
- Collaborates with the Process Improvement narrative automation team to develop patient safety narratives
Qualifications
- College or university degree, preferably a Bachelor’s / Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
- Minimum 2 years of corresponding industry experience working with clinical documentation and data
- Prior pharmaceutical, biotechnology, or contract research organization experience
- Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
- Basic knowledge of electronic Common Technical Document (eCTD) requirements
Additional Information
Associate Medical Writer.
In support of the Quality Control Associates and if assigned by the Associate Director, Medical.. and summarizes data from clinical studiesReviews scientific literature pertinent to medical writing..
Technical Writer
Technical Writer (f m d). FrameMaker. Ixiasoft. ST4. German. internationalProject. For our customer.. Checks documents or topics written by other technical writers, ensuring that terminology and content..
Technical Writer
EINFÜHRUNG. As a preferred supplier for Roche Diagnostics in Rotkreuz, we are looking for a motivated Technical Writer (m f d) 100. The contract has a unlimited duration. The earliest start..
Technical Writer (m/f/d)
BeschreibungFor our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Technical Writer for one year with option for..
Technical Writer
JETZT BEWERBENDRUCKEN https. www.elan personal.ch stellenangebote job details technical writer m f d.. Hoffmann La Roche AG in Basel & Kaiseraugst, we are looking for aTechnical Writer (m f d)Background..
Technical Writer
The International Partner Markets (IPM) TA Medical Manager will be strategic for gaining medical.. to support IPM medical and addressing the medical need in IPM and help prepare ort he anticipated..
Medical Manager
The International Partner Markets (IPM) TA Medical Manager will be strategic for gaining medical.. This position will be responsible for contributing to the set up of the IPM medical roadmap and strategy..
Technical Writer (f/m/d)
In alignment with other KLE sub chapters and relevant stakeholders.Checks documents or topics written by other technical writers, ensuring that terminology and content creation guidelines have..
Technical Writer (m/f/d)
Job Description. We seek an experienced Technical Writer to join our team, who will become the owner of.. Experience as a Technical Writer in the machinery industry Experience with Adobe Framemaker, Adobe CC..
Technical Writer (f/m/d)
Job Description. We seek an experienced Technical Writer to join our team, who will become the owner of.. Education, Experience, and Certifications. Experience as a Technical Writer in the machinery industry..