Senior Technical Writer

1 week ago

Woodcliff Lake, New Jersey, United States PDI Full time

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team

POSITION PURPOSE

PDI is seeking a Sr Technical Writer to support our New and Existing Product Development (NPD/EPD) pipeline for products in the drug (OTC, DIN, NHP), medical device, cosmetic, disinfectant (EPA, DIN) and general household products areas. The Sr Technical Writer will lead and drive the technical (CMC) writing to accelerate the development of small molecules, combination drug/device products, and other innovative materials for areas with high unmet medical needs.

The Sr Technical Writer is responsible for coordinating reporting needs with project teams, regulatory strategies, and product development timelines. The incumbent will build out the technical capabilities of the R&D team by implementing best practices for report writing, documentation, and drug development expertise.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

  • Prepares and/or assists in the coordination and preparation of scientific documents under minimal supervision to meet or exceed quality standards.
  • Drafts eCTD written and tabulated summaries, investigator brochure content, FDA briefing packages, and other agency related technical documents, in collaboration with Regulatory teams.
  • Leads the compilation, writing, and editing of high-quality module 3 documents in collaboration with SMEs (material scientists, engineers, analytical chemists, and microbiologists).
  • Reviews GLP reports prior to EPA submission.
  • Works closely with clinical development teams, including clinical scientists, clinical affairs, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents.
  • Actively facilitates internal reviewer comment reconciliation and assesses agency responses.
  • Writes, edits, and reviews scientific documents including, but not limited to analytical, microbiological, and packaging methods; method development summaries; method verification, validation, and transfer protocols and reports; standard operating procedures and work instructions; customer-facing technical briefs; claims reports; and/or specifications.
  • Reviews scientific documents for accuracy, formatting, consistency, and compliance with scientific principles, regulatory guidelines, company standards, and industry best practices.
  • Provides technical writing expertise, best practices training, and support to project teams, contributing to strategic planning and decision-making.
  • Develops templates, guidelines, and standardizes writing, formatting, use of statistics, and figures department wide.
  • Stays current with industry trends, guidelines, and best practices, and shares knowledge with the team.

PERFORMANCE MEASUREMENTS

  • Meet key project milestones and timelines.
  • Able to communicate (written, verbal) with other team members, cross functional teams, and leadership effectively. Communicate scientific findings clearly to a wide variety of audiences (technical, leadership, consumer) and make meaningful contributions to projects.
  • Ensure implementation of robust processes and procedures that maintain compliance to all applicable GxP regulations, Company and Department procedures/policies
  • Support work stream timelines and be able to balance priorities according to stakeholder needs.
  • Demonstrate ability to add value to the organization through scientific excellence.
  • Take ownership of assigned projects and self-lead initiatives.

QUALIFICATIONS

EDUCATION/CERTIFICATIONS:

  • PhD in Chemistry Preferred, or a combination of scientific BS/MS degree with equivalent industry experience

REQUIRED KNOWLEDGE:

  • Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), scientific principles, and GCP/GLP/GMP guidelines.
  • In-depth understanding of chemistry in the product development pipeline (synthesis/manufacturing process, impurities, analytical procedures, reference standards, stability studies).
  • Expert knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
  • Good working knowledge of scientific terminology, medical, pharmaceutical, and research concepts.
  • Working knowledge of analytical and/or microbiological laboratory procedures.
  • Knowledge of eCTD formatting and EDMS systems preferred.

EXPERIENCE REQUIRED:

  • Advanced Degree with 3+ years of relevant technical writing experience, BS Degree with 7+ years of relevant technical writing experience
  • CMC technical writing/authoring experience for small molecules or devices.
  • Experience with regulatory submissions (NDA/ANDA/IND) strongly preferred.

SKILLS/ABILITIES:

  • Meticulous written and verbal communication skills.
  • Exceptional command of written and spoken English.
  • Digital literacy (Word, Excel, Adobe, Teams, scientific software and databases)
  • Proficiency with document templates, document toolbars, and proper version control.
  • Excellent editorial and proofreading skills
  • Strong project management skills. Organized and self-motivated.
  • Strong attention to detail and ability to maintain scientific rigor.
  • Ability to work well in a collaborative team environment

WORKING CONDITIONS:

  • NONE: No hazardous or significantly unpleasant conditions.

SALARY RANGE:

  • $90,000 - $110,000 Annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

  • Medical, behavioral & prescription drug coverage
  • Health Savings Account (HSA)
  • Dental
  • Vision
  • 401(k) savings plan with company match and profit sharing
  • Basic and supplemental Life and AD&D insurance
  • Flexible Spending Accounts (FSAs)
  • Short & long-term disability
  • Employee Assistance Program (EAP)
  • Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

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