12/21/2023 0 Comments Medical writing associate![]() ![]() Proclinical Staffing is an equal opportunity employer.Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! ![]() Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) or. The employee must be able to communicate via telephone, written correspondence, or spoken word in order to perform the essential duties of the position.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.External Medical Writing Vendors (individual consultant writers and CROs).Teams within the Global Groups and Medical and Regulatory Affairs department: Medical Planning and Management Physicians, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research.Competency in the use of Documentum (or a similar document management system) is desired.Team player who is cost-conscious, adaptable to change, accepts new challenges, excellent organization skills, quality focused, with proven analytical and problem-solving abilities.Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers.Excellent written/oral communication skills and highly proficient word processing skills.Demonstrated medical writing skills and a high-level interpersonal skill to interact effectively in team and matrix work settings.Working knowledge of worldwide registration document requirements, including ICH guidelines, EMA requirements, and FDA guidelines and requirements.Experience with interactions with regulatory groups and formulating regulatory strategies desirable.Vendor/consultant management experience preferred. ![]() Experience with diagnostic imaging agents preferred.7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers.degree required, advanced degree/Life Sciences preferred. Prepare/review SOPs, Working Guides, and document templates.Review medical documents generated outside of Medical Writing (e.g., study protocol, Statistical Analysis Plan, tables and listings).Act as a Medical Writing coordinator for the preparation of drug safety-related documents such as PSURs/PBRERs.Provide status reports for ongoing projects. ![]()
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