Technical Writer

Job Description

• Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (i.e. Global vs. Country/Region) It may be helpful to complete this section after you have finished the other sections of the document

• Incumbent will assist in the creation, review and revision of documents (SOPs, forms, jobs aids, training material, etc.) and other manufacturing department documents

• Incumbent will work with co-workers and supervisors to understand the objective of each document to ensure that all documents contain the required content

• Incumbent will interpret information and organize it properly for accuracy, readability and format, while ensuring the proper grammar and spelling is used in all documents

• Perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures

• In order of importance, list the primary responsibilities critical to the performance of the position

• It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required

• Edit and format incoming requests for new or revised documents (SOPs, forms, jobs aids, training material, etc.) and assist in tracking each revision through the approval workflow

• Provide assistance with development of new and revised documents including suggestions for suitable terminology, content, and format while ensuring that site policies comply with Corporate guidelines

• Participate in the bi-annual review of Standard Operating Procedures, forms and other related documents

• Complete commitments as assigned to facilitate Corrective Actions/Preventative Actions

• Participate in the bi-annual review of Standard Operating Procedures, forms and other related documents

• Complete commitments as assigned to facilitate Corrective Actions/Preventative Actions

• Assist in maintaining control of documentation to include accurate document history and change revision documentation

Organizational Relationships-

• Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities

• Include any external interactions as appropriate

• There is interaction between site departments

• The position also interacts with network customers on an as needed basis

o Supply Chain, Manufacturing, Quality, Compliance, Technical Operations

o Network Customers

Resources Managed-

• Financial Accountability

• Indicate the Average Budget or Revenue accountability, as applicable

• Supervision

• Indicate the typical number of Colleagues managed

• Include direct & indirect reports, matrix responsibility and or additional resources (i.e. contingent workers), as applicable

Qualifications

• Bachelor’s degree in Science, Communications, or English, with at least 2 years related experience in technical writing, preferably in a pharmaceutical or related environment

• AS in Communications or related field with minimum of 5 years related experience in technical writing, preferably in a Biopharmaceutical or other regulated environment

• Experience writing SOPs

• At least 5 years technical writing experience

Technical Skills-

• Able to edit documents quickly and efficiently to incorporate required revisions

• Develops and applies standardized document formats where applicable

• Able to learn and navigate document control and E-Systems to facilitate document routing and approval

• Able to effectively proofread documents prepared by self and others for content and others to ensure accuracy

• Able to write clearly and concisely with strong English background with excellent grammar, good writing skills and knowledge of sentence structure

• Effective active listening skills

• Able to translate verbal guidance into precise operating instructions

• Adheres to and applies standard document formats while maintaining technical content of new and revised documents

• Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self

• Incorporates insights of other people into ongoing work

• Able to learn and understand pharmaceutical processes in order to design related SOPs

• Understanding of cGMP and Safety regulations

• Strong organizational and communication skills

• Team based collaborative problem solving

• Strong understanding of cGMPs

Additional Information

Thanks

Regards

Ricky Bansal

732-429-1925