job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Bridgewater, New Jersey
job type: Contract
salary: $45.75 - 53.82 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
The CMC Regulatory Technical Writer works closely with quality, manufacturing, regulatory, and technical staff from global locations within the industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 CMC regulatory submissions for development and post-approval dossiers in eCTD format. The CMC Regulatory Technical Writer also authors change controls, following the change control procedures.
The technical writer contributes to various US, EU and rest of world (ROW) registrations. They author and create dossier content from source documentation for registrations, and provide writing support for technical reports. Recommend table of contents for regulatory submissions. Contribute to regulatory strategy for successful product registration. Assess questions received from health authorities and author responses. Ensure all dossiers are in compliance with the company templates, regulatory guidance, and ICH guidance, and maintain up to date knowledge. Maintain skills required for dossier related software systems.
qualifications: Education & Qualifications
- BS/BA or MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
- 7 years experience in the pharmaceutical industry, which includes no less than 4 years of experience with CMC regulatory related activities.
- The candidate must possess substantial Chemistry, Manufacturing and Controls (CMC) and Common Technical Document (CTD) authoring experience. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have at least 7 years' experience in the industry. Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is mandatory. A working knowledge of cGMP's is desired. Experience with CMC documentation pertinent to various dosage forms is needed.
- This position requires the incumbent to be highly organized, self-motivated, and able to independently manage multiple priorities. The desired candidate will have the capacity to be productive with very little supervision, and should enjoy writing. Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact with a multi-disciplinary team. Knowledge of US pharmaceutical regulations is essential. Exposure to non-US regulatory activities is desired, but not mandatory.
skills: CMC, Analytical Chemistry, Biology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.