Senior Medical Writing Lead for Regulatory Submissions

Planet Pharma; Plainsboro Township (NJ); Sur place; USD 131 000 - 145 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Senior Manager, GDS&PV Medical Writer (Contractor) to contribute to the medical writing portfolio across regulatory submissions and clinical documentation, including CTD/eCTD formats and Health Authority responses.

This role leads writing activities, develops templates, and drives process improvements within a global Medical Writing team, ensuring high quality deliverables on timelines and aligning with ICH guidelines and regulatory requirements.

Qualifications

• Approximately 6-8+ years of relevant medical writing experience within the pharmaceutical or biotechnology industry, including experience independently leading complex clinical and regulatory documents.
• Demonstrated experience authoring and investigator’s brochures, clinical summaries/overviews, briefing documents, and Health Authority responses.
• Strong knowledge of clinical development, regulatory submission requirements, CTD/eCTD structure, ICH guidelines, and applicable global regulatory requirements.
• Experience leading medical writing activities for regulatory submissions, including document planning, cross-functional reviews, timeline management, and resolution of complex reviewer comments.
• Proven ability to interpret and communicate complex clinical and scientific data clearly, accurately, and consistently for regulatory and scientific audiences.
• Strong project management, communication, and cross-functional collaboration skills, with the ability to represent Medical Writing on study teams and manage multiple priorities.
• Experience contributing to medical writing standards, templates, processes, and continuous improvement initiatives, with a demonstrated commitment to quality and knowledge sharing

Responsabilités

• Document Creation and Review – Independently author and review clinical and regulatory documents, including clinical trial protocols, amendments, and reports.
• Prepare and review investigator’s brochures, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions.
• Draft and edit Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts).
• Team Leadership and Collaboration – Represent medical writing on cross-functional teams and lead submission activities.
• Facilitate document preparation, scheduling meetings, developing timelines, and managing document reviews and decisions.

Description du poste

Planet Pharma is seeking a Senior Manager, GDS&PV Medical Writer (Contractor) to contribute to the medical writing portfolio across regulatory submissions and clinical documentation, including CTD/eCTD formats and Health Authority responses.

This role leads writing activities, develops templates, and drives process improvements within a global Medical Writing team, ensuring high quality deliverables on timelines and aligning with ICH guidelines and regulatory requirements.