Principal Medical Writer

We are currently seeking Senior or Principal Medical Writer to join our diverse and dynamic team. At this role you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards.

We hire at Medical Writer 2, Senior Medical Writer or Principal Medical Writer level

What You Will Be Doing:

Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.

• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.

• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications

• Provides review and substantive editing of contributions, and ensures resolution of issues.

• Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to  regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.

• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).

• Acts as a key Medical Point of contact for clinical regulatory strategy

• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.

• Provides leadership on functional teams that address requirements or issues related to document preparation and production.

• The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.

Your Profile:

• Bachelor’s degree in science, health profession required

• At least 5 years of experience writing for pharma or biotechnology preferred . 3+ years of electronic documents and submissions required.

• Experience as lead writer for key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols 

• Experience managing writing activities for a major  international regulatory submission preferred.

Knowledge and Skills: 

• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.

• Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).

• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.

• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers

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