Senior Medical Writing Manager

Job Description

Plainsboro, NJ - Hybrid (onsite 2-3 days per week)

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6 Month Initial Contract - Potential for Extension

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Pay: $95-$105/hr

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The Senior Manager, GDS&PV Medical Writer is responsible for contributing to the medical writing portfolio within the clinical and regulatory areas. This includes authoring and contributing to the authoring of briefing documents, clinical trial medical synopses, protocols, investigator’s brochures, PIPs, CSRs, Health Authority briefing books, Health Authority responses, and other clinical documentation to support the conduct of trials and regulatory submissions/filings. The Senior Manager, GDS&PV Medical Writer participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. The Senior Manager proactively engages in departmental activities and lessons learned to share insights, lead various initiatives, and contribute to supporting a global organization.

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Responsibilities:

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Document Creation and Review

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- Independently author and review clinical and regulatory documents, including clinical trial protocols, amendments, and reports.

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- Prepare and review investigator’s brochures, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions.

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- Draft and edit Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals). Team Leadership and Collaboration:

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- Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams.

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- Lead or participate in submission team activities.

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- Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions.

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Process Development:

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- Lead or participate in the development and review of standard processes and templates.

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- Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.

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- Maintain current knowledge and competencies within relevant therapeutic and professional areas.

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- Contribute to knowledge sharing, skill-building, and good collaboration with stakeholders and colleagues.

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Regulatory and Quality Adherence:

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- Maintain up-to-date knowledge of relevant regulatory guidelines and requirements.

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- Adhere to guidelines, SOPs, practices, and technical standards in all aspects of work

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Qualifications:

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Independently prepare, edit, and finalize complex clinical and regulatory documents including clinical trial protocols/amendments, investigator’s brochures, and clinical study reports

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Independently draft and edit Health Authority briefing packages, Health Authority responses, and clinical CTD submission documents

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Serve as compound lead writer and medical writing representative on cross-functional study teams and provide guidance on document strategy and content, timelines, and resource needs to ensure timely completion of tasks with desired quality

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Manage smooth and effective document management from start to finish (i.e., from template to a final approved version) for a project/ trial

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Actively drive development of templates and establishment of medical writing processes and standards

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Recommend and lead process improvement initiatives and actively participate in inter-and intra-departmental knowledge sharing sessions

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Requirements:

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- Approximately 6–8+ years of relevant medical writing experience within the pharmaceutical or biotechnology industry, including experience independently leading complex clinical and regulatory documents.

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- Demonstrated experience authoring and investigator’s brochures, clinical summaries/overviews, briefing documents, and Health Authority responses.

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- Strong knowledge of clinical development, regulatory submission requirements, CTD/eCTD structure, ICH guidelines, and applicable global regulatory requirements.

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- Experience leading medical writing activities for regulatory submissions, including document planning, cross-functional reviews, timeline management, and resolution of complex reviewer comments.

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- Proven ability to interpret and communicate complex clinical and scientific data clearly, accurately, and consistently for regulatory and scientific audiences.

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- Strong project management, communication, and cross-functional collaboration skills, with the ability to represent Medical Writing on clinical development and regulatory teams and manage multiple priorities and timelines.

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- Experience contributing to medical writing standards, templates, processes, and continuous improvement initiatives, with a demonstrated commitment to quality, knowledge sharing, and development of best practices