Responsibilities:

1. Independently author and/or collaborate with appropriate representatives from NCD disciplines (Toxicology and Drug Metabolism & Pharmacokinetics) and Pharmacology/Translational Medicine for technical writing of reports for non-GLP exploratory toxicology studies and/or nonclinical pharmacology studies conducted within Celgene Translational Development or Experimental Toxicology/Therapeutics and/or by external collaborators.
2. Work with Regulatory Operations department and NWD Document Specialists to maintain the electronic study report repository, and manage the Author, Review, and Approval process for electronic submission documents.
3. Represent NCD Toxicology functions on submission teams and in collaboration with functional leads to devise and implement the strategy for document preparation as per timelines agreed upon by the functions and submission team.
4. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
5. Be an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
6. Facilitate document review meetings, resolution meetings, and discussions as needed pertaining to comment resolution leading to the on-time completion of a high quality document.
7. As needed, 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 are produced within the NWD Function.
8. Examine existing NWD procedures and make recommendations to enhance NWD policies and procedure, internal document controls, and work practices to improve overall NCD document quality.
9. Other duties as assigned

Qualifications
Prerequisite:
Advanced degree in biological/toxicological or related sciences (MS or PhD) with 3 to 5 years of professional scientific writing experience
Skills/Knowledge Required:
• Advanced degree in biological/toxicological or related sciences (MS or PhD) with 3 to 5 years of professional scientific writing experience.
• 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 Food and Drug Administration (FDA) submissions, and nonclinical & regulatory documents included in registration dossiers for worldwide use.
• Familiarity with toxicology, in vivo animal studies, pharmacokinetics, pharmacology, cell biology, and biochemistry required.
• Knowledgeable in nonclinical drug development process including good laboratory practices (GLP) toxicology and safety pharmacology IND enabling studies.
• Knowledge of the FDA and ICH guidelines pertaining to new chemical entity development and regulatory submissions to global health authorities.
• Excellent scientific writing and verbal communication skills. Demonstrated ability to compile concise summaries of complicated data sets.
• Proficient 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.
• Ability to work with multiple complex projects and within cross-functional teams.