Senior Medical Writing Manager

Meet Life Sciences; Plainsboro Township (NJ); Presencial; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

Meet Life Sciences Ltd. in Plainsboro, NJ seeks an experienced Senior Medical Writing Manager to independently lead clinical and regulatory documentation for trials and global submissions.

This hands-on role requires strong pharma/biotech medical writing experience, cross-functional collaboration, and the ability to drive content quality within timelines. A senior candidate will guide strategy and improve templates and processes across departments.

Qualificações

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field; advanced degree preferred.
• Approximately 6–8+ years of medical writing experience in pharma/biotech.
• Experience independently authoring and leading complex clinical/regulatory documents.
• Experience developing clinical trial protocols, amendments, investigator brochures, and CSRs.
• Experience preparing Health Authority briefing documents, regulatory responses, and clinical submission content.
• Strong understanding of clinical development, CTD/eCTD, ICH guidelines, and global regulatory requirements.
• Experience coordinating regulatory submission documentation, including planning, cross-functional reviews, and reviewer comments resolution.
• Ability to interpret complex data and communicate findings clearly.
• Excellent project management, organizational, communication, and stakeholder management skills.
• Ability to manage multiple documents and priorities in a fast-paced global environment.

Responsabilidades

• Independently author, edit, and finalize complex clinical and regulatory documents (protocols, amendments, ICH brochures, CSRs, and clinical synopses).
• Develop and review Health Authority briefing packages and regulatory correspondence.
• Prepare clinical summaries and regulatory submission content in CTD/eCTD format.
• Serve as the lead writer on cross-functional clinical study and regulatory submission teams.
• Guide document strategy, timelines, resources, and deliverables.
• Coordinate document development from templates through finalization.
• Lead cross-functional document review processes and align final content.
• Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, and stakeholders to ensure accuracy and quality.
• Contribute to templates, processes, standards, and best practices in medical writing.
• Identify opportunities to improve workflows and collaboration.

Conhecimentos

Medical writing

Regulatory submissions

CTD/eCTD

Project management

Cross-functional teamwork

Formação

Bachelor's degree in Life Sciences

Advanced degree preferred

Descrição da vaga

Seeking an experienced Senior Medical Writing Manager to support clinical development and regulatory documentation within a leading global biopharmaceutical organization. This is a hands-on opportunity for a medical writing professional to independently lead the development, review, and finalization of complex clinical and regulatory documents supporting clinical trials and global regulatory submissions.

The ideal candidate will bring strong pharmaceutical or biotechnology medical writing experience, a deep understanding of clinical development and regulatory requirements, and the ability to collaborate cross-functionally to deliver high-quality documentation within established timelines.

Key Responsibilities

• Independently author, edit, and finalize complex clinical and regulatory documents, including clinical trial protocols, amendments, investigator’s brochures, clinical study reports (CSRs), and clinical synopses.
• Develop and review Health Authority briefing packages, briefing books, responses, and other regulatory correspondence.
• Prepare and contribute to clinical summaries, overviews, and regulatory submission documents in CTD/eCTD format.
• Serve as the compound lead writer and medical writing representative on cross-functional clinical study and regulatory submission teams.
• Provide guidance on document strategy, content, timelines, resource requirements, and deliverables.
• Coordinate document development from initial templates through review, approval, and finalization.
• Lead cross-functional document review processes, including scheduling meetings, managing reviewer comments, and driving alignment on final content.
• Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, and other stakeholders to ensure accuracy, consistency, and quality.
• Support the development and continuous improvement of medical writing templates, processes, standards, and best practices.
• Identify opportunities to improve document workflows, cross-functional collaboration, and overall medical writing efficiency.
• Maintain current knowledge of applicable regulatory guidelines, ICH requirements, and industry standards.
• Contribute to departmental knowledge sharing, training, and continuous improvement initiatives.

Required Skills

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline; advanced degree preferred.
• Approximately 6-8+ years of medical writing experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience independently authoring and leading complex clinical and regulatory documents.
• Strong experience developing clinical trial protocols, amendments, investigator’s brochures, and clinical study reports.
• Experience preparing Health Authority briefing documents, regulatory responses, and clinical submission content.
• Strong understanding of clinical development, CTD/eCTD structure, ICH guidelines, and global regulatory requirements.
• Experience coordinating regulatory submission documentation, including document planning, cross-functional reviews, timelines, and resolution of reviewer comments.
• Ability to interpret complex clinical and scientific data and communicate findings clearly and accurately.
• Excellent project management, organizational, communication, and stakeholder-management skills.
• Ability to manage multiple documents and priorities independently in a fast-paced, global environment.

Preferred Qualifications

• Experience serving as a compound lead writer or medical writing representative on clinical development teams.
• Experience supporting global regulatory submissions and Health Authority interactions.
• Familiarity with PIPs and other clinical and regulatory development documentation.
• Experience developing medical writing templates, SOPs, processes, and quality standards.
• Experience preparing scientific publications, including abstracts, posters, slide presentations, and journal manuscripts.
• Experience collaborating with global, cross-functional teams across Clinical Development, Regulatory Affairs, and Pharmacovigilance.
• Demonstrated ability to lead process improvement initiatives and share medical writing best practices.