CMC Regulatory Technical Writer II

Akkodis is seeking a Technical Writer II (Scientific) Position role is a 12 Month's Contract with Client.

Position- Technical Writer II (Scientific)

Location- Morristown NJ (Remote)

Pay Range: $45-50/hr. (The Rate may be negotiable based on experience, Education, Geographic Location, and other factors.)

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

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 Sanofis templates

- collaborating and coordinating with key stakeholders across the GBUs, 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 Sanofi's ways of working, SOPs, and CMC regulations and guidelines

- supporting the planning and preparation of timelines

Skills and 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 cGMPs 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.

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).

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance