Director, Lead Regulatory Writer (Remote)

Job Description Summary: The Director, Lead Regulatory Writer leads, authors, edits and provides input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. They may also author/edit and/or direct the development of pre-clinical documents. The incumbent works cross-functionally with internal departments and external resources on Scientific Writing related issues. They will manage a team of direct reports.The Director, Lead Writer will collaborate 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.Job Description:Responsibilities: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 prepare clinical documents, including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, and summary modules under strict timelines.Provides leadership in planning and completing multiple 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).Ensures key messages are clear and consistent within and across documents.Contributes strategically and scientifically at the project, study team, and submission level.Leads and oversees multiple drug programs, including coordination of writing resources and strategic contribution to messaging.Provides editorial or review support and/or strategic guidance 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 ensure accurate and timely completion/delivery of high-quality, scientifically justified documents.Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.Proactively initiates improvements in Scientific Writing processes, including, for example, the development and standardization of templates.Serves as subject matter expert at conferences and professional meetings to demonstrate the expertise of PTC's writing group and to contribute to the Medical Writing field as a whole.Coaches/mentors other writers in submission tasks and strategies, providing support for internal process improvement outside of Scientific Writing across the organization.Assists in the day-to-day operational activities and other assignments as needed and specified by management.Manages a team of direct reports.Provides coaching/mentoring to other writers for study level documents as well as submission level documents.Qualifications:Advanced degree (PhD or PharmD) with 10+ years in medical writing experience in pharmaceutical industry OR Bachelor's degree in a scientific discipline with 10+ years of experience in a pharmaceutical, biotechnology, or CROs, including participation in submissions to the US FDA (NDA, BLA) and/or EMA (MAA).Demonstrated advanced experience in the preparation of all regulatory and clinical documents.Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data.Excellent understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts, including their application to regulatory strategy.Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.Ability to influence without direct authority and practice blameless problem solving.Proficiency with Microsoft Office and use of electronic document templates.Excellent verbal and written communication skills.Ability to work independently and to lead, as required, 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.Demonstrate leadership by example within Scientific Writing, and to the wider organization.Special knowledge or skills and/or licenses or certificates preferred.Ability to assist with other regulatory or clinical tasks.Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.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.Experience in writing manuscripts for publication.Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates.Travel requirements: Approximately 10îO Statement: Click here to return to the careers pagePTC 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, p regnancy, 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.

Created: 2024-11-02