CMC Regulatory Technical Writer II

Title: CMC Regulatory Technical Writer II

Location: 100% Remote

Job Duration: 12 months (Contract, possibilities of extension)

Description:

• The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in client's lifecycle management (LCM) programs. They collaborate directly with client's global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU and rest of world (ROW) dossiers (e.g. NDA, MAA, IND, and IMPD).

Key Responsibilities:

The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines. This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs.

The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:

- following regulatory guidelines, source documentation, and client's templates
- collaborating and coordinating with key stakeholders across the GBU s, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
- avoiding unsolicited regulatory burden
- supporting the development of regulatory risk mitigation strategies
- maintaining up-to-date knowledge of client's ways of working, SOPs, and CMC regulations and guidelines
- supporting the planning and preparation of timelines

Skills & Experience:

• Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3). A background in pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have at least 5 years' experience in the pharmaceutical industry. Expertise with document management systems such as Veeva or Documentum is a plus. A working knowledge of cGMP s is desired. Experience with MS suite of software applications is expected. This role predominantly focuses on small molecules, and some aseptically manufactured products. Medical device experience is a plus.
• Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team. The candidate needs very little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated. Knowledge of US pharmaceutical Regulations is essential. Exposure to ex-US Regulations is desired, but not mandatory.

Education:

• BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).

Comments:

• Fully Remote If candidate is local Morristown, Hybrid would be required. Paid parking is required is nearby and there is nearby public transportation.
• Must Have: Number of years of experience: 3-5 years Must Have: authoring experience (Modules 2 and 3) Ability to work independently CMC regulations/ scientific background is required MS Office - must have
• Nice to Have: Veeva or Documentum is a plus Medical device experience is a plus