BioSpace · 20 hours ago

Manager, Scientific Writing

United States

Full-time

Remote

Mid, Senior Level

$124K/yr - $203K/yr

7+ years exp

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Comp. & Benefits

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Responsibilities

Coach writers on preparation of regulatory submission documents with PPK content with a focus on genetics medicine throughout the entire document life cycle including content development, drafting, reviews, comment reconciliation, quality control, formatting, adherence to style guides, approval, and upload to file repositories.

Develop processes and guidance documents for preclinical PK submission content (including Toxicokinetics) for emerging genetic medicine modalities in collaboration with the PK Subject Matter experts, Regulatory Affairs, and other relevant stakeholders.

Manage team of writers, assign deliverables, and ensure regulatory compliance.

Participate in relevant cross-functional meetings to ensure adherence to overall submission timing and strategy.

Work together with other line managers within the Scientific Writing team, in particular your counterpart managing PPK for Protein Therapeutics, to ensure consistency in messaging, language, and quality across nonclinical content.

Provide training and support professional development of direct reports and other mentees.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory submission draftingECTD knowledgeDrug development understandingPreclinical PK contentGenetic medicines knowledgeTeam managementProcess development