The Director, Scientific Writing directs provides leadership and technical and operational support to the activities of the scientific writing staff and associated projects. The Director Scientific Writing is part of a matrix team dedicated to the planning, writing, and completion of global regulatory submissions for small molecule and gene therapy products.
The key duties include, but are not limited to:
Provide leadership managing team of in-house and external Medical Writers
Provides support in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports).
Guide team of external and in-house Medical Writers in planning & preparation of 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 Harmonization (ICH) guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
Work with leads from cross-functional internal departments in planning and preparation of high quality clinical and regulatory documents within assigned time lines. This includes, but is 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.
Works cross-functionally to support the development of CMC and CCDS/labeling, publication, and market access documents
Ensures key messages are clear and consistent within and across documents.
Lead team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices
Contributes strategically and scientifically at the project and/or study team level.
Build team of external writers to ensure flexibility and quality deliverables
Provides editorial or review support for other types of documents, such as abstracts, posters, and presentations for scientific meetings and journals
Assists in the daytoday operational activities and other assignments as needed and specified by management.
Minimum level of education and years of relevant work experience:
Advanced degree (PhD. MD, or PharmD) with a minimum of 8 years of medical writing experience in a pharmaceutical company or related environment OR a Bachelor’s degree in a scientific discipline with 12 years of medical writing experience
Special knowledge or skills needed and/or licenses or certificates required:
Supervisory experience leading team working on early and late phase studies
US FDA (NDA, BLA) and/or EMA (MAA experience with active contribution in planning and preparation of summary documents
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.
Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data.
Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
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.
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:
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.
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.