Senior Technical Writer

System One Services
Oct 07, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Senior Technical WriterHawthorne, NY




Category:Scientific & Clinical

Job ID:89299

Date Posted:08/08/2016

Senior Technical Writer

Cranbury NJ

Senior Technical Writer needed for well-established pharmaceutical company in Cranbury, NJ. This position offers excellent compensation and benefits!


The Senior Technical Writer is responsible for working within the Technical Writer Matrix team, influencing process, tool and template improvement, helping to facilitate alignment across multiple Functional Manuals. The Senior Technical Writer will author technical documents such as Global Policies, Global Quality Standards, and Global SOPs in partnership with functional are subject matter experts ensuring these documents are written to a comprehensive level, and agreed upon by key stakeholders. Additionally this role will ensure all documents they author are aligned to compendial, ICH and FDA and other regulatory guidance expectations.

The Senior Technical writer ensures all written documents conform to approved document format, standards, style, and terminology. The Senior Technical Writer will work with eDMS system to ensure proper workflows are utilized and appropriate review and approval occurs.


+ Develop and Manage Functional Document Manual (API, OD, Sterile, R&D)

+ Develop and Manage Functional Area relationships that will benefit document development

+ Maintain industry knowledge regarding regulatory agencies, guidance and industry practices to ensure Policies, standards, and GSOPs are developed in conformance with regulatory expectations

+ Provides input into the Annual Functional Manual Program Management Master Plan (in partnership with Technical Writer Matrix Team)

+ Provides input to departmental dashboards that illustrate progress and effectiveness of ongoing development activities

+ Act as a contributing member of the GQS Governance Committee, ensuring consistent approaches to document development and site implementation as appropriate

+ Manages technical writing issues, identifies and manages risks and deliverables

+ Must be able to facilitate discussions and broker consensus between all stakeholders.

+ Must be able to define program acceptance and success criteria.

+ Will work directly with the cross functional team members or with their team leaders to estimate effort, plan activities and negotiate consensus among individual team members on their appointed tasks.

+ Responsible for bringing the documents through to implementation

+ Conducts periodic meetings to ensure transparency of activities, and assure lessons learned are captured for future use.

+ Ability to function as a leader, or work as part of a matrix team.

Experience Requirement

+ Minimum of 7-10 years working in a pharmaceutical environment

+ At least 5 years technical writing experience within a Pharmaceutical Quality Environment

+ Knowledge of project management principles, practices, techniques and tools

+ Broad understanding of R&D, drug development, manufacturing processes, and quality

+ Bachelor's degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required, with a MA preferred.

+ Project Management experience

+ Excellent written and verbal skills

+ Technical expertise with SharePoint, MS Office, and eDMS

Please apply on-line or email resumes to


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