The Senior Manager, Quality Control Review, Scientific Writing provides technical and operational support to the activities of the quality control review staff and associated projects. This includes, but is not limited to: reviewing, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also review and provide editorial support for the development of pre-clinical documents.
The Senior Manager, Quality Control Review, Scientific Writing collaborates on the development of clinical documents in accordance with all applicable regulations including, but not limited to, Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association (EMA) Clinical Trials Directives, International Congress on Harmonisation (ICH) guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
The incumbent works cross-functionally with internal departments and external resources on Quality Control Review related issues.
In adherence with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits:
Works with the clinical and regulatory teams to conduct quality control reviews to ensure accuracy and consistency within and across clinical documents including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview, and pre-clinical study protocols and reports under strict timelines.
Contributes to, and provides oversight for, the completion of major summary submission documents to ensure high-quality submission dossiers.
Provides editorial or quality control review support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC, etc.) to provide quality control reviews to ensure accurate and consistent information within and across documents from such functions.
Ensures timely completion/delivery of high-quality reviews.
Ensures timely completion/delivery of high-quality reviews.
Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.
Procures and manages external quality control review resources (e.g., Contract Research Organizations (CRO), freelance quality control reviewers, etc).
Contributes to the development and standardization of templates and related processes. Manages, coaches, and mentors direct reports.
Assists in the daytoday operational activities and other assignments as needed and specified by management (e.g., metrics for Scientific Writing, Instructions for CSR Appendices).
* Minimum level of education and years of relevant work experience.
Advanced degree (PhD or PharmD) in a relevant, scientific discipline and a minimum of 5 years of quality control experience in a pharmaceutical company or related environment OR a Master’s degree in a scientific discipline and a minimum of 6 years of related experience in a pharmaceutical, biotechnology, CRO or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
At least 6 years of experience in a quality control role, including participation in submissions to the US FDA (NDA, BLA) and/or EMA (MAA).
Demonstrated experience in quality control review of protocols, study reports, investigator brochures, safety updates, and IND clinical sections.
Excellent understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts.
Excellent attention to detail, including fact checking, logical flow, parallelism, 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.
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 and to complete high-quality documents according to tight timelines.
*Special knowledge or skills and/or licenses or certificates preferred.
• Ability to assist with other regulatory or clinical tasks.
• Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents.
• Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools.
• Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates.
• Demonstrated project management experience.
* Travel requirements
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Office-based position (optionally remote)
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.