Contract SOP/Technical Writer, System Document Management at PTC Therapeutics in SOUTH PLAINFIELD, New Jersey

Job Description:

 
The Contract SOP/Technical Writer, supports the System Document Management processes by collaborating with authors and Subject Matter Experts (SMEs) to revise or create SOPs, Work Instructions, forms, checklists, manuals, and training quizzes. This involves collecting and consolidating input from cross functional stakeholders, developing process maps, reviewing current GxP regulatory requirements (ICH guidelines, FDA CFRs, EMA directives, etc.) company SOPs and developing them into clear and concise procedures.  The Contract SOP/Technical Writer is responsible for applying appropriate document templates, standards, style and terminology across documents.
 
The incumbent works cross-functionally with internal departments and external resources on GxP related procedural documents. 
 
The Contract SOP/Technical Writer, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:
 
Collaborates with GxP SMEs and teams to write, review or edit technical GxP documents (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) in a clear, concise format.
Performs document QC checks as required.
Ensures good documentation practices are followed.
Coordinates with various departments to assure GxP document written are indicative of the process and understandable to the reader.
Acts as liaison between QA and the department that the document is being written for.
Performs other related tasks and assignments as needed and specified by management related to document generation and control.

 
* Minimum level of education and years of relevant work experience.
 
Bachelor’s degree in a scientific discipline and a minimum of 5 years of technical GxP document writing experience (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) in the pharmaceutical, biotechnology, contract research organization or related environment/industry, or recognized equivalent of education and experience (minimum level of education required – Associates degree.)

 
* Special knowledge or skills needed and/or licenses or certificates required.
 

Ability to plan, write, review, and edit technical GxP documents (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) and ensure that these documents adhere to applicable regulatory FDA, EMA, ICH guidelines and standards.

 Experience in working in a GXP environment.

Strong technical comprehension and writing capability.

Experience with inProcess mapping and collaborative document development.

Excellent attention to detail, including fact checking, logical flow, formatting, and document structure.

Proficiency with Microsoft Office and use of electronic document templates.

Excellent verbal and written communication skills.

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

 
*Special knowledge or skills and/or licenses or certificates preferred.
 
Broad knowledge of ICH guidelines, FDA CFRs, EMA directives and other regulatory guidelines.

Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to write high quality documents according to tight timelines.

Experience working with Electronic Data Management Systems (EDMS)

Excellent interpersonal skills and attention to detail.

Technical writing certification a plus