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Technical Writer

  • Location: New Brunswick, Middlesex, New Jersey
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 18 September 2021

Job Description:

Key Responsibilities and Major Duties

  • The technical writer positions are responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls: Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management.

Technical Writers skills/competence, experience/knowledge, and Responsibilities:

Skills/Competence:

  • Excellent technical writing skills.

  • Expert in MS Office and Collaboration applications.

  • Experience with electronic documentation management systems (preferable, not required)

  • Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.

  • Strong verbal and written communication skills

  • Project management concepts, strategies and skills

  • Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures

Experience/Knowledge:

  • In depth knowledge of cGxP requirements (includes GMP, GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.

  • Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations

  • Strong negotiating and influencing skills in a matrixed organization.

  • Ability to drive consensus, performance and to lead strategically

  • High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas

  • Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner

  • Demonstrated ability to work independently

Responsibilities:

  • Includes, but not limited to, document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.

  • Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.

  • Support Global Product Development & Supply organization for client  electronic document management system.

  • Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes

  • Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans

  • Effectively participate on projects, escalate issues as necessary and identify/meet key milestones

  • Work with limited guidance to manage the development of global procedural documents and, seek input as needed

  • Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies

  • Ability to identify, manage, and/or escalate issues and risks to timelines

  • Collects and shares best practices through direct communications and communities of practice

Education

  • Minimum of a Bachelors degree

  • 5+ years experience in the Biopharm/Pharmaceutical industry

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.