Technical Writer

Sibitalent Corp; Morristown (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a CMC Regulatory Technical Writer II to join their dynamic team. In this pivotal role, you will contribute to the lifecycle management of pharmaceutical products by authoring high-quality regulatory documents. You will collaborate with global business units and ensure compliance with regulatory guidelines, all while working in a multidisciplinary environment. This is an exciting opportunity for someone with a strong background in CMC and CTD authoring, as well as a passion for the pharmaceutical industry. If you are detail-oriented and thrive in a fast-paced setting, this role offers the chance to make a significant impact in the field.

Qualifications

• 5+ years of experience in the pharmaceutical industry required.
• Candidates must have CMC and CTD authoring experience.
• Knowledge of US pharmaceutical regulations is essential.

Responsibilities

• Develops and authors CMC common technical documents for regulatory dossiers.
• Handles responses to health authority inquiries and regulatory amendments.
• Ensures regulatory dossier compliance and authors high-quality CMC content.

Skills

CMC authoring experience

CTD authoring experience

Pharmaceutical manufacturing

Quality control/assurance

Document management systems (Veeva, Documentum)

Knowledge of cGMPs

MS Office proficiency

Interpersonal communication skills

Organizational skills

Knowledge of US pharmaceutical regulations

Education

BS/BA in a science/health field

MS in a science/health field

PhD in a science/health field

Tools

Veeva

Documentum

MS Office

Job description

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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