Newark Metro Area, New Jersey
Responsibilities will include, but are not limited to, the following:
1) Entry level technical writer to author/review analytical development documents and stability reports. Zero to 5 years experience is what we're looking for. Accordingly, the your Bill Rate submissions should reflect the level of experience.
2) Summarize, transcribe and document analytical data and evaluation findings to be used in IND, NDA, CTD applications and other regulatory documentation to Health Authorities.
3) Review data to determine the appropriate tabular and textual formats, in particular for clarity, logic, order of presentation and accuracy.
4) Working with relevant technical and subject matter experts to extract and document information for the reports.
5) Follow internal corporate and department guidelines for document preparation.
6) Follow templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
7) Participate in study and project team meetings and assist the teams in resolving issues related to document preparation.
8) Facilitate document review meetings and discussions.
9) Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements.
10) Other duties/responsibilities as assigned.
Skills / Knowledge:
Must have proficient technical writing and verbal communication skills.
Must be proficient in use of Microsoft Word, Excel. Person needs basic knowledge of Excel in order to enter and track data and be able to create Pivot Tables.
Familiarity with GMP and pharmaceutical analysis techniques, health authority filings such a Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for Food and Drug Administration (FDA) submissions, and nonclinical & regulatory documents with registration dossiers for worldwide use is preferred.
Familiarity with Data graphics software, Adobe Acrobat, and web-based browser software such as Documentum to manage electronic document authoring, reviewing, and approval process is preferred.
Ability to work with multiple complex projects and within cross-functional teams is preferred.