Technical Writer II

Pyramid Consulting, Inc; United States; Remote; USD 68,880 - 77,145; Full time

Benefits offered by this job

Health insurance (medical, dental, vision)

401(k) plan

Paid sick leave

Job summary

A leading consulting firm is seeking a Technical Writer II for a 12+ month contract position. This role, which is remote, involves developing and authoring CMC technical documents for regulatory submissions. Ideal candidates should have over 5 years in the pharmaceutical industry, experience with CMC and CTD authoring, and excellent communication skills. Knowledge of US pharmaceutical regulations is essential. This is an excellent opportunity for those looking to grow in the field of regulatory writing.

Qualifications

• 5+ years of experience in the pharmaceutical industry.
• Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience.
• Excellent interpersonal communication skills are required.

Responsibilities

• Develops and authors CMC common technical documents for regulatory dossiers.
• Collaborates with key stakeholders across various functional areas.
• Maintains up-to-date knowledge of regulations and client standards.

Skills

Regulatory submission

Technical Writer/Regulatory Writing

Authoring

CMC Regulatory Authoring

MS Suite of software applications

Education

BS/BA, MS, or PhD in a science/health field

Tools

Veeva

Documentum

Job description

Pyramid Consulting, Inc provided pay range

This range is provided by Pyramid Consulting, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $56.00/hr

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 CMC regulations 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
• 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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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