Technical Writer Job at Sibitalent Corp in Morristown
Sibitalent Corp, Morristown, NJ, United States, 07961
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Note: Must have 5 years of experience in Pharma..........................................
Job Description
The CMC Regulatory Technical Writer II is a member of the CMC Dossier Development team and participates in Our Client’s lifecycle management (LCM) programs. They collaborate directly with Our Client's global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU, and ROW dossiers (e.g., NDA, MAA, IND, and IMPD).
Key Responsibilities:
- Develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within established timelines.
- Handles responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Authors and evaluates change controls for global regulatory impact. May also author technical reports, position papers, white papers, or SOPs.
*** Ensures regulatory dossier compliance and independently authors high-quality CMC content by:
- Following regulatory guidelines, source documentation, and client templates
- Collaborating with key stakeholders across GBUs, contract manufacturing organizations (CMO), and functions such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
- Minimizing unsolicited regulatory burden
- Supporting development of regulatory risk mitigation strategies
- Maintaining up-to-date knowledge of Our Client's SOPs and CMC regulations and guidelines
- Supporting planning and timeline management
Skills and Experience
- Candidates must have CMC and CTD authoring experience (Modules 2 and 3).
- Background in pharmaceutical manufacturing or quality control/assurance is a plus.
- Minimum 5 years' experience in the pharmaceutical industry required.
- Experience with document management systems such as Veeva or Documentum is advantageous.
- Knowledge of cGMPs is desirable.
- Proficiency with MS Office applications expected.
- Focus on small molecules and some aseptically manufactured products; medical device experience is a plus.
- Excellent interpersonal communication skills and ability to work within a multidisciplinary team.
- Self-motivated, organized, detail-oriented, and able to manage priorities independently.
- Knowledge of US pharmaceutical regulations is essential; exposure to ex-US regulations is a plus.
Education
- BS/BA, MS, or PhD in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or related).
Seniority level
- Mid-Senior level
Employment type
- Contract
Job function
- Information Technology
Industries
- IT Services and IT Consulting