Technical Writer II

Immediate need for a talented Technical Writer II. This is a 12 months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-94864

Pay Range: $50 - $56/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

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.
• Following regulatory guidelines, source documentation, and client 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 ways of working, SOPs, and CMCregulations and guidelines
• The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:
• Supporting the planning and preparation of timelines"

Key Requirements and Technology Experience: 

• Key skills; Regulatory submission, Technical Writer/ Regulatory Writing, Authoring

• CMC Regulatory Authoring
• Regulatory submissions
• Bachelor Degree
• 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 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."

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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