Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionResponsibilities:Clinical / medical writing experience – pref. in oncologyExperience at bringing together submission content (Mod 2.5, 2.7 etc)Experience at working with internal clinical SMEs, pulling together their content into briefing documents / submission contentPrior knowledge of Pfizer systems is desirable but not mandatory East coast based preferablyWrite, edit, and format various regulatory documents, publications, and presentation materials for NDA submissionCoordinate document review cycles, incorporate comments, and collect signatures for finalizationDevelop and maintain timelines for document/publication review and finalizationAssist in the development of in-house medical writing materials for NDA submission (such as SOPs and style guide)Provide quality control (QC) review of various regulatory documentsCollaborate with others and effectively represent Medical Writing/ Clinical Regulatory on inter-departmental project teamsQualificationsA minimum of a BS degree and 3 years’ experience in a pharmaceutical, biotech or CRO environmentDemonstrated solid knowledge and Experience in Medical Writing and/ or Clinical Regulatory (IND, NDA, briefing books, DSUR, Literature Writing etc.)Recent experience with an NDA submission desiredExperience writing and managing clinical regulatory documentsKnowledge of science and clinical research conceptsThe ability to understand and summarize clinical dataWriting ability for different types of clinical and regulatory documentsKnowledge of FDA and ICH guidelinesDemonstrated solid project management skillsProven experience in working in a high volume environment handling multiple tasksExcellent time and priority management, able to work efficiently under pressureWorks accurately and to detailStrong organizational skillsStrong computer skills, including Word, PowerPoint, and ExcelExcellent grammatical and communication skills, both written and oralExpertise with electronic publishing desiredProven ability to interact seamlessly and collaboratively with client in a consulting relationshipAdditional InformationAll your information will be kept confidential according to EEO guidelines.