Comrise - Bridgewater Township, NJ

posted 20 days ago

Full-time - Senior
Bridgewater Township, NJ
Professional, Scientific, and Technical Services

About the position

The Sr. Technical Writer/Process Compliance position is a critical role focused on creating, updating, and maintaining technical product documentation in alignment with the company's Development Life Cycle (DLC) process. The primary objective is to ensure that all documentation is comprehensive, user-friendly, and adheres to the highest standards of quality. This role requires a deep understanding of the company's product offerings and the ability to quickly learn complex technical products across various sectors and service areas. The successful candidate will engage in product training sessions, interact with product interfaces, and collaborate closely with Agile teams to grasp core product releases. Additionally, the role involves working with various internal stakeholders, including Product Development Managers, Architects, Project Managers, and Operations teams, to control and manage core product DLC release documentation sets. The responsibilities extend to managing electronic libraries for tracking release documentation packages, coordinating the signing, approval, and publication of these documents, and reporting on department metrics. This includes gathering and analyzing data related to product quality, resource utilization, and adherence to training metrics. The candidate will also provide general coordination and support for departmental and team projects as needed. Exceptional writing, editing, and proofreading skills are essential for producing engaging and error-free content. The role involves performing readability and audience analysis, ensuring clarity and accuracy in documentation, and maintaining stylistic consistency across various document families. The position also encompasses the creation and maintenance of various process and DLC deliverable documents, such as Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs), System Requirements Specifications (SRS), Design Specifications, API Guides, Architectural Overviews, System Diagrams, User Guides, Online Help, Training Materials, and Style Guides. The candidate will be responsible for preparing technical documentation for clients, updating online Help material, generating and publishing online Help systems, and supervising other staff contractors as needed. Overall, this role is pivotal in ensuring that all technical documentation meets the required standards and effectively supports the company's operational goals.

Responsibilities

  • Gain in-depth knowledge of company product offerings and Development Life Cycle (DLC) processes.
  • Quickly learn complex technical products and develop comprehensive user-friendly documents, diagrams, charts, and workflows.
  • Attend product training sessions and interact with product interfaces.
  • Work closely with Agile teams to understand core product releases.
  • Collaborate with internal stakeholders such as PDM, Architects, PJM, and OPS.
  • Control core product DLC release documentation sets.
  • Manage electronic libraries and lists for tracking release documentation packages.
  • Coordinate signing, approval, and publication of release documentation.
  • Report on department metrics, including product quality and resource utilization.
  • Provide general coordination and support to department and team projects as needed.
  • Utilize exceptional writing, editing, and proofreading skills to produce engaging and error-free content.
  • Perform writing, editing, readability, and audience analysis tasks.
  • Conduct editing reviews to ensure clarity, conciseness, grammar, and accuracy.
  • Review and update current style guide and format standards as needed.
  • Provide editorial oversight to maintain document integrity and stylistic consistency.
  • Maintain secure DLC documentation archives.
  • Create and maintain Process and DLC deliverable documents, including SOPs, SWIs, SRS, Design Specifications, API Guides, Architectural Overviews, System Diagrams, User Guides, Online Help, Training Materials, and Style Guides.
  • Prepare technical documentation for clients and update online Help material.
  • Generate and publish online Help systems.
  • Coordinate and supervise other staff contractors as needed.

Requirements

  • Undergraduate/graduate degree in Technical/Science Communication, Business Information Systems, Computer Science, Computer Applications, Quality Engineering, Life Sciences, or equivalent.
  • Minimum 10+ years as a technical writer.
  • Experience writing, editing, and updating Development Life Cycle documents/artifacts within an R&D/Engineering environment following a SAFe/Agile methodology.
  • Domain experience within the Pharmaceutical, Biotechnology, Medical Devices, Health Care, or other Regulated Industry.
  • Knowledge of the complete spectrum of technical writing and print production processes.
  • Expert-level knowledge of Microsoft Word, Excel, PowerPoint, Adobe Acrobat Professional, PDF file creation, and image applications or equivalent tools.
  • Expert-level knowledge of RoboHelp Online Help systems or equivalent.
  • Excellent written and communication skills.
  • Detail-oriented with experience updating end-user software Online Help and/or printed guides.

Nice-to-haves

  • Familiarity with regulatory compliance documentation in the pharmaceutical or medical device industries.
  • Experience with content management systems (CMS) for documentation management.
  • Knowledge of graphic design tools for creating diagrams and charts.

Benefits

  • Health insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Flexible scheduling options
  • Professional development opportunities
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