Job ID: 14885
Location: Summit, NJ
Offsite Territory: Regular/Temporary:
Department: NCD - Administration - 3254
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Advanced degree in biological/toxicological or related sciences (MS or PhD) with 3 to 5 years of professional scientific writing experience.
1. Independently author and/or collaborate with appropriate representatives from NCD disciplines (Toxicology and Drug Metabolism & Pharmacokinetics) and Pharmacology/Translational Medicine for writing scientific documents such as nonclinical regulatory electronic submission documents, investigator brochures, annual reports, and/or study reports.
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
- Advanced degree in biological/toxicological or related sciences (MS or PhD).
- Experience in regulatory toxicology. Previous experience in the pharmaceutical industry/contract research organization as a study monitor and/or study director is preferred.
- Three to 5 years of previous experience independently authoring scientific publications, study reports, or nonclinical regulatory electronic submission documents preferably in pharmaceutical related fields.
- Previous experience as a nonclinical toxicology writer that included writing the toxicology contributions in the electronic Common Technical Documents (eCTD) format for Investigational New Drug (IND; United States Food and Drug Administration [FDA]), New Drug Application (NDA; FDA), and Marketing Authorization Application (MAA; European Union) is desired.
- Knowledgeable in nonclinical drug development process including good laboratory practices (GLP) toxicology and safety pharmacology IND enabling studies.
- Knowledge of the “Guidance for Industry” pertaining to new chemical entity development and regulatory submission to FDA and other global health authority regulatory bodies.
- Excellent scientific writing and verbal communication skills. Demonstrated ability to compile concise summaries of complicated data sets.
- Advanced skills 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 within cross-functional teams.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Deadline: 10 January 2014