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Technical Writer II
Pyramid Consulting, Inc provided pay rangeThis 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/hrImmediate 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: 25-94864Pay 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, AuthoringCMC Regulatory AuthoringRegulatory submissionsBS/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.By applying to our jobs you agree to receive calls, AI‑generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.#J-18808-Ljbffr
Skills:
Analytical Chemistry, Artificial Intelligence (AI), Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Communication Skills, Consulting, Contract Manufacturing, Current Good Manufacturing Practice (cGMP), Detail Oriented, Document Management, Documentation, Documentum Enterprise Content Management (ECM) System, Drug Manufacturing, Employee Benefits, Equal Employment Opportunity (EEO), Genetics, Health Science, Interpersonal Skills, Manufacturing, Manufacturing Requirements, Medical Equipment, Medical Products, Organizational Skills, Pharmacy, Position Papers, Quality Assurance, Quality Control, Regulations, Regulatory Compliance, Regulatory Submissions, Reporting Skills, Risk Management, Short Messaging Service (SMS), Small Molecules, Standard Operating Procedures (SOP), State Laws and Regulations, Technical Writing, White Papers
About the Company:
Pyramid Consulting
