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Senior Scientific Writer, Nonclinical Pharmacology / Toxicology

Req #: 1700820
Location: Summit, NJ US
Job Category: Medical
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities include:

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 CTD 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. Technical writing of reports for non-GLP exploratory toxicology or nonclinical pharmacology studies conducted by or on behalf of Celgene. Participate in submission team meetings and manage and drive timelines for 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 become informed in upcoming needs for nonclinical writing. Implement the strategy for document preparation and NCD review. 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.

Skills/Knowledge Required:

  • Advanced degree in pharmacology/toxicology or related sciences (MS or PhD) with 3- 5 years of nonclinical scientific writing experience.
  • 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 in nonclinical development including toxicology, pharmacokinetics, and discovery pharmacology.  Knowledge of FDA and ICH guidelines.

Ability to work with multiple complex projects and 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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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