Lead Technical Writer, Clinical AI​/ML & SaMD

Position: Lead Technical Writer, Clinical AI/ML & SaMD

Location: All US Locations/Remote

Job : 201

# of Openings: 1

We are seeking a Lead Writer to partner closely with a Program Manager in developing high‑stakes federal proposals (e.g., ARPA‑H, BARDA, SBIR) for industry‑focused clients. The work will span regulated clinical AI and adjacent biomedical AI product development, including SaMD clinical support tools, autonomous patient‑facing and clinical workflow agents with post‑deployment oversight and safety monitoring, computer‑vision image analysis systems, and AI‑enabled medical devices (including edge AI and/or surgical robotics), with additional exposure to computational AI for drug discovery.

This is NOT a general grant‑writing or editing role; we need someone who can shape reviewer‑credible technical narratives at the intersection of clinical AI/digital health development and deployment, rigorous validation and safety monitoring, SaMD regulatory and authorization requirements, and milestone‑driven program design.

This role requires exceptional technical writing and cross‑functional synthesis, fluency in AI/ML development and validation, and the ability to handle multiple concurrent projects each with varying deadlines for execution. The ideal candidate is comfortable bridging next‑generation innovation with real‑world execution—able to see what may be technically possible and translate it into a plan that can be responsibly proposed, rigorously evaluated, and ultimately deployed to improve human health.

This position is part‑time or full‑time. Individuals with superior skills and a demonstrated track record will be considered for immediate full‑time hire.

• Serve as a senior, client‑facing proposal architect and lead writer for ARPA‑H and related federal R&D pursuits in clinical AI/digital health.
• Work directly with external clients (founders, clinicians, technical teams, consortium partners) to shape proposal strategy, technical framing, and reviewer‑facing narrative.
• Partner with internal proposal managers to align on timelines, deliverables, and submission workflows.

• Draft all major proposal sections (not just outlines or edits), including technical narrative, significance/impact, innovation, work plan, milestones, evaluation/validation strategy, risk/mitigation, and related supporting sections as applicable.
• Translate solicitation requirements and client inputs into clear, cohesive, submission‑ready draft content.
• Build proposal structure (work streams/technical areas, dependencies, milestones, go/no‑go logic) and write it into a reviewer‑credible narrative.
• Lead working sessions with external clients to extract technical and clinical content.
• Iterate drafts directly with clients through review cycles, incorporating feedback while preserving clarity, coherence, and strategic positioning.
• Resolve gaps, contradictions, and unsupported claims across sections.
• Drive revision cycles toward a coherent, technically credible, reviewer‑ready final proposal.

• PhD preferred
  . Master’s Degree in biology, biochemistry, biomedical engineering, other life science, or relevant background, essential.
• Minimum 1‑year scientific writing experience, preferably in a healthcare/research/academic environment.
• Proven experience writing grants, including NIH SBIR proposals, and/or experience with other funding mechanisms.
• Demonstrated ability to shape technical narratives for AI/ML, digital health, and software‑enabled healthcare technologies in real deployment contexts.
• Strong fluency in AI/ML technology development, clinical validation concepts, implementation and deployment realities, and regulatory/authorization constraints.
• Proven ability to operate under ambiguity and deadline pressure while improving rigor.

• Critical Evaluation:
  Objectivity, critical thinking, problem solving, curiosity, inquisitiveness, research methodology, knowledge management, online search skills.
• Communication for Impact:
  Exceptional verbal and written communications skills, command of the English language, strong presentation skills, diplomacy, perceptual objectivity, active listening, asking the right questions.
• Understanding of healthcare industry trends, regulations, and emerging technologies associated with software and digital health.
• Relationship Building:
  Trustworthy, competent, client‑focused, credible, proactive and responsive, values the team environment, and works with mutual respect.
• Flexibility:
  Ability to handle changing priorities and multiple concurrent deadlines while maintaining high quality final products.
• Ethical Practice:
  Personal and professional integrity, builds trust and rapport.

Competitive salary commensurate with experience. Bonus eligible.