The Contract, Technical Writer - CMC supports the CMC team by collaborating with authors and Subject Matter Experts (SMEs) to revise or create documents that include, but may not be limited to, Standard Operating Procedures (SOPs), Batch/Lab records, Qualification/Validation protocols and Development/Qualification/Validation Reports. This involves collecting and consolidating input from cross functional stakeholders, reviewing current documents and developing them into clear and concise procedures. The incumbent is also 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, Technical Writer - CMC supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Collaborates with GxP Subject Matter Experts (SMEs) and teams to write, review or edit technical GxP documents (and where/when required, verify data) in a clear, concise format.
Performs document QC checks as required.
Ensures good documentation practices are followed.
Coordinates with various departments to assure that GxP document(s) clearly are indicative of the process and understandable to the reader.
Acts as liaison between CMC, Regulatory Affairs, and Quality Assurance, as well as representatives of third parties, 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 relevant discipline and a minimum of 5 years of technical GxP document writing relevant documents in a pharmaceutical, biotechnology, contract research organization or related environment/industry OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.
Must have some technical knowledge of laboratory procedures in the Biologics/Gene & Cell Therapy fields (molecular biology, immunoassay, cell/bioassay)
Ability to plan, write, review, and edit technical GxP documents 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 process 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.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*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.
Excellent interpersonal skills and attention to detail.
Technical writing certification.
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.