Technical Writer II (Scientific)

Position: CMC Regulatory Technical Writer II, Req#: SNFIJP00009855
Location: Morristown, NJ (Remote). However, if local to the Morristown area, it will be expected hybrid.

Work Schedule: 8 am-5 pm EST, Mon-Fri (manager will adjust hours based on candidate's time zone)
Duration: 12+ Months Contract

Job Description:

The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in the client’s lifecycle management (LCM) programs. They collaborate directly with the 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).

Education and Experience: 

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

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 the 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 the client’s ways of working, SOPs, and CMC regulations and guidelines
• Supporting the planning and preparation of timelines