Overview:
PTC Therapeutics is seeking an experienced Associate Director, Lead Writer to oversee and provide technical and operational support for scientific writing activities. This role involves directing the creation and management of clinical documents, regulatory submissions, presentations, posters, publications, and pre-clinical documents. You will work cross-functionally with internal departments and external resources, managing a team of direct reports.
Responsibilities:
Document Preparation: Research, author, and edit clinical documents such as Clinical Study Reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, and summary modules in accordance with Good Clinical Practice (GCP), regulatory guidelines (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines), company SOPs, and internal style guides.
Regulatory Submissions: Lead the preparation and planning of key regulatory submissions to US and global health authorities, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports. Ensure clarity and consistency of key messages across documents.
Strategic Contribution: Provide strategic and scientific input at the project and study team levels. Offer editorial support for abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
Cross-functional Collaboration: Work closely with various teams (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC) to ensure accurate and timely completion of high-quality documents.
Document Presentation: Maintain consistency in document presentation and adherence to company standards. Contribute to the development and standardization of templates and processes.
Operational Support: Assist with daily operational activities and other tasks as assigned by management. Provide coaching and mentoring to junior staff on study-level and submission-level documents.
Qualifications:
Education: Advanced degree (PhD or PharmD) with 8+ years of medical writing experience in the pharmaceutical industry, or a Bachelor’s degree with 10+ years of experience in pharmaceutical, biotechnology, or CRO environments, including experience with US FDA (NDA, BLA) and/or EMA (MAA) submissions.
Experience: Proven expertise in preparing protocols, study reports, investigator brochures, safety updates, and NDA/IND Summary documents. Experience in writing manuscripts for publication and using Adobe Acrobat and eCTD templates.
Skills: Excellent communication and writing skills with the ability to present data clearly and effectively. Strong understanding of biostatistics reporting standards and attention to detail. Ability to influence without direct authority and lead submission teams. Proficiency with Microsoft Office and electronic document templates.
Additional: Broad knowledge of EMA/ICH guidelines and FDA guidance. Ability to manage multiple projects, adapt to changing priorities, and work independently and collaboratively in a fast-paced environment. Experience with PubMed and other reference tools is preferred.
Travel: Approximately 10%.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We are committed to providing equal employment opportunities to 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 strive to treat all applicants fairly and avoid discrimination.
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