Specialist II, Quality Control Review and Editing (GROW)

Job Description Summary:

The Specialist II, Quality Control Review and Editing performs quality control (QC) review and editing of regulatory documents and provides support to the development of high-quality documents for regulatory fulfillment to health authorities using appropriate processes, tools, and technology. The Specialist II, Quality Control Review and Editing works cross-functionally with internal departments and external resources on QC, editing, and Global Regulatory Operations and Writing related projects.

Job Description:

Responsibilities:

• Works with cross-functional teams (eg, PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC) to perform QC review (data verification against source documents and internal consistency checks) and editing of complex clinical and nonclinical regulatory documents including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator’s Brochures (IBs), submission modules, and preclinical study protocols and reports.
• Provides QC, editorial, and submission support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
• Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.
• Works within and across functions to assist in the improvement, development, and implementation of QC and editing processes, templates, checklists, and best practices.
• May assist in the design and presentation of QC and editing training on topics including, but not limited to, EndNote, PTC Therapeutics (PTC) Style Guide, PerfectIt, PTC checklists, and best practices.
• Contributes to the completion of key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications [NDAs], Marketing Authorisation Applications [MAAs], Investigational New Drug [IND] submissions, and annual reports).
• Assists with day-to-day operational activities and other assignments as needed and specified by management (eg, Scientific Writing Metrics).

Qualifications

Bachelor’s degree or higher, preferably in a scientific discipline, and a minimum of 2 years of related experience, preferably in a pharmaceutical, biotechnology, or related environment, OR equivalent education and/or transferable experience.

• Excellent attention to detail, including fact checking, logical flow, parallelism, and document structure.
• Demonstrated experience in writing, QC review, and/or editing documents having scientific/medical or complex technical content.
• Ability to QC and/or edit a variety of clinical and scientific regulatory documents and ensure that these documents adhere to applicable regulatory guidelines and standards.
• Proficiency with Microsoft Office (ie, WORD, EXCEL).
• 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.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects simultaneously, while maintaining high-quality results.
• Proficiency in Adobe Acrobat and Electronic Technical Common Technical Documents (eCTD) templates preferred.
• Experience with IND and NDA/MAA submissions preferred.
• Experience with EndNote, PowerPoint, SharePoint, Teams, Veeva, and use of electronic document templates preferred.
•  Travel requirements: 0-10%. Remote or hybrid option.

EEO Statement:

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.

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