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CMC Technical Writer

Req #: 1701226
Location: San Diego, San Diego US
Job Category: Medical
Work Location: 3033 Science Park Road Suite 300 RCPTSD 92121
Organization: Receptos, Inc.
Schedule: 40
Employee Status: Full time
Job Type: Regular
Job Level:
Other Locations:US- CA- San Diego- Science Park


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.

Core Responsibilities and Duties:

  • The technical writer will also be responsible for all CMC Technical Development Reports including developing document templates, defining timelines for documents production, review and approval cycles.
  • Establish and maintain CMC documents achieve system.
  • Review all CMC scientific documents intended for external publication.
  • Problem Solving – Identify critical path activities and coordinate with responsible parties to ensure deliverables are achieved. Facilitate resolution to keep project activities on track.
  • CMC Technical Writer will be responsible for writing CMC regulatory documents (IND, IMPD, NDA, MAA) and preparation of all necessary supporting documents including CMC responses to regulatory agencies while coordinating with the CMC team on the technical writing effort in regulatory filings.
  • Collaborate with internal functional areas and external partners to ensure the production and review of CMC documents within agreed upon timelines.


Education & Experience

  • MS or higher degree with 5 years or BS with 10 years or more experience in a life sciences, engineering, or equivalent technical CMC drug development experience in a biopharmaceutical company.  An advanced degree (MS or PhD) would be a plus.
  • Demonstrated technical documentation and database management skills, with a proven track record of successfully working in interdisciplinary teams from early through late stage clinical development.
  • Experience working with ex-US CMOs and/or business partners.
  • Experience with document templates, editing, publishing and formatting essential with strong computer skills including knowledge of good document management practices.
  • Extensive experience in coordinating the preparation and review of CMC documentation for Regulatory filings.
  • Excellent planning, communication and documentation skills. Familiarity with planning tools.

Knowledge Requirements:

  • Solid understanding of drug development and manufacturing with an emphasis on knowledge capture and management.
  • Familiarity with global Regulatory requirements (FDA, EMA, etc.) including FDA and ICH guidelines, drug development and approval process, and MAA writing style and document templates.
  • Strong computer skills including versatility with Microsoft Word, Excel, PowerPoint, Microsoft Project, Adobe Acrobat, and graphic packages as well as database management.

Personal Competencies:

  • Ability to effectively manage multiple responsibilities, tasks, and projects simultaneously in a fast-paced environment. 
  • Excellent oral and written communication skills.  Ability to communicate clearly, and to present experimental results and analysis, and persuasively present recommendations.
  • Effective interpersonal skills.  Ability to work in a team-oriented, cross-functional environment, and effectively manage diverse personalities and styles, and lead by influence.
  • Demonstrated ability to proactively evaluate and independently develop solutions to complex problems.
  • Self-motivated, independent, and results-oriented with initiative to complete tasks independently.  Capacity to organize assignments and work within deadlines.
  • Ability to work effectively in as a team player.  Intensely committed to success and getting the job done well in a dynamic environment.
  • Strong analytical and organizational skills; highly attentive to details.
  • Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.

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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