Technical Writer; Pharmacology/Toxicology in Nonclinical Writing & Documentation Group
Newark Metro Area, New Jersey
Technical writing of reports for non-GLP exploratory toxicology or nonclinical pharmacology studies conducted by or on behalf of
Working independently and with other relevant line functions to prepare/review scientific summaries and regulatory documents and submissions, including: nonclinical summaries for IND, NDA, and CTA applications to Health Authorities, white papers, Investigator Brochures, Phase I clinical protocols, company core data sheets, product monographs/package inserts, and responses to health authorities.
Participate in submission team meetings, and manage and drive timelines for nonclinical portions of submissions.
Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
Be an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
Participate in study and project team meetings and assist the teams in resolving issues related to document preparation.
Work with NWD Document Specialist and Regulatory Operations department to initiate and maintain electronic study report and published literature repository, and contribute to the authoring, review, and approval process for documents within an electronic publishing system.
Attend Product Development Team meetings and Department Group Meetings as needed to develop understanding of upcoming needs for nonclinical writing.
Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements in order to ensure high quality documents.
Other duties/responsibilities as assigned.
Excellent technical scientific writing and verbal communication skills required.
Must have experience as a nonclinical toxicology, pharmacokinetics, and/or pharmacology writer that included contributions to Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for FDA and worldwide regulatory documents.
Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process. Experience with MS Project a plus.
Experience in nonclinical development including toxicology, pharmacokinetics, and discovery pharmacology.
Knowledge of FDA and ICH guidelines related to nonclinical activities. Knowledge of the Standard for Exchange of Nonclinical Data a plus
Ability to work with multiple complex projects and within cross-functional teams.
Advanced degree in biological/toxicological or related sciences (MS or PhD) with 5 years of professional scientific writing experience. ***Minimum of MS REQUIRED.