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Form of workJob Title:Technical Writer - NJ
Location: Summit NJ
Duraation:7+ Month
Responsibilities will include, but are not limited to the following:
1. Technical writing of reports for non-GLP nonclinical pharmacology and/or exploratory toxicology studies conducted within *** Translational Development or Experimental Toxicology/Therapeutics and/or by external collaborators.
2. Writing of nonclinical pharmacology summaries for IND, NDA, and CTD applications to Health Authorities.
3. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
4. Working with other relevant line functions to prepare/review regulatory documents and submissions, including Investigator Brochures, Phase I clinical protocols, integrated summaries of efficacy and safety, registration dossiers, company core data sheets, product monographs/package inserts, and responses to health authorities.
5. Follow internal 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. Work with NCD 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 electronic documents.
9. Attend Product Development Team meetings and Department Group Meetings to become informed in upcoming needs for nonclinical writing.
10. Implement the strategy for document preparation and NCD review that includes time frames that meet or exceed company standards and the document review processes. 11. Facilitate document review meetings and discussions.
12. Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements.
13. Other duties/responsibilities as assigned. Skills/Knowledge Required: Excellent technical writing and verbal communication skills required. Good publication record, if emerging from an academic (doctorate or post-doctoral fellowship) program, required. If previously employed as a Technical Writer, must have experience with 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. Familiarity with techniques of cell biology, biochemistry, pharmacology, pharmacokinetics, and/or toxicology required; first-hand laboratory experience is a plus. Proficiency in use of Microsoft Word, Excel, data graphics software, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process. Knowledgeable in nonclinical development including discovery pharmacology, pharmacokinetics, and/or toxicology etc. Knowledge of FDA and ICH guidelines. Ability to work with multiple complex projects and within cross-functional teams.
Location: Summit NJ
Duraation:7+ Month
Responsibilities will include, but are not limited to the following:
1. Technical writing of reports for non-GLP nonclinical pharmacology and/or exploratory toxicology studies conducted within *** Translational Development or Experimental Toxicology/Therapeutics and/or by external collaborators.
2. Writing of nonclinical pharmacology summaries for IND, NDA, and CTD applications to Health Authorities.
3. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
4. Working with other relevant line functions to prepare/review regulatory documents and submissions, including Investigator Brochures, Phase I clinical protocols, integrated summaries of efficacy and safety, registration dossiers, company core data sheets, product monographs/package inserts, and responses to health authorities.
5. Follow internal 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. Work with NCD 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 electronic documents.
9. Attend Product Development Team meetings and Department Group Meetings to become informed in upcoming needs for nonclinical writing.
10. Implement the strategy for document preparation and NCD review that includes time frames that meet or exceed company standards and the document review processes. 11. Facilitate document review meetings and discussions.
12. Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements.
13. Other duties/responsibilities as assigned. Skills/Knowledge Required: Excellent technical writing and verbal communication skills required. Good publication record, if emerging from an academic (doctorate or post-doctoral fellowship) program, required. If previously employed as a Technical Writer, must have experience with 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. Familiarity with techniques of cell biology, biochemistry, pharmacology, pharmacokinetics, and/or toxicology required; first-hand laboratory experience is a plus. Proficiency in use of Microsoft Word, Excel, data graphics software, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process. Knowledgeable in nonclinical development including discovery pharmacology, pharmacokinetics, and/or toxicology etc. Knowledge of FDA and ICH guidelines. Ability to work with multiple complex projects and within cross-functional teams.
