Ingrid Witherell

I will add runway to your assets. Who I Am: I’m a 25-year Swiss-army-knife veteran medical writer, safety researcher, and regulatory-intelligencer who brings full lifecycle experience to early clinical development. I'm a First Principle thinker who had incredible mentors that trusted me to build airfields of infrastructure as draft guidelines circled overhead (ICH E3, E6, CTD, E2C(R2), GPV, RMP). I train like a samurai between projects, devouring guidelines as beach reading. I surveil postmarket safety like Batman (and protect patients from pseudoscience in my off hours). Governed by practicality and data/decision traceability, I focus small clinical teams on issues that matter to stakeholders and discourage familiar and ineffective routines. Finally, I WRITE like an LLM in research mode, but with human sentences, judgment, and far fewer hallucinations, and I EDIT by decoding documents that read like ransom notes. What I’ve Done: I’ve set the anchors of regulatory reporting and publications for tiny biotech, merging pharma, and established pharma. I have10+ authorships EACH of INDs, DSURs, IBs, CSRs, CTD sNDA/ NDA summaries, PBRERs, RMPs, labelling updates, signal reviews, and FDA meeting packages. My batting average for manuscripts and abstracts hovers around .35 and my regulatory deadlines get met. My filings and publications anticipate questions and draw few comments (my preferred metric). Work I support gets approved (regulatory meetings and labelling updates) and paths I create are future blueprints long after I depart (governance, templates, needs assessments). I'm a seasoned pro at launch-adjacent work: audit readiness, safety-surveillance preparation, MLR review, and coordinated publication launches. What I’ll Do: Send me a DM that mentions your company name, company type if not specified (CRO, medcom, biotech [stage], pharma) stage, therapeutic area, and 3 pain points. I will send you a 1 page explanation.