Technical Writer

Company Description

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

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