About
We are an AI startup building specialized AI tools for complex life sciences workflows.
We are looking for a medical writer (or safety/PV expert) with recent, hands-on experience authoring PSURs or PBRERs.
While there are no therapeutic or modality requirements, the team would have a preference for consultants with Immunology, Dermatology, and/or Medical Device experience.
IMPORTANT NOTE - This is a micro-engagement. The selected consultant should expect 1-2 hours in TOTAL. The client is looking for one expert to advise/provide insights/Q&A in a one or two 1 hour virtual meetings with the team. Clora will process payment to the selected consultant immediately following a Client-approved billable activity, which may include meetings and meeting preparations.
Responsibilities
- Participate in live working sessions with our team (e.g., video calls) to walk through current-state of authoring PSURs or PBRERs, answer detailed process questions, and provide real-time feedback as we design and refine AI-supported solutions.
- Share practical, end-to-end insight into how PSUR / PBRER authoring operates at small and large life sciences organizations, including stakeholders involved, handoffs, input materials, review cycles, timelines, and common pain points.
- Provide asynchronous support as needed, including reviewing materials, responding to ad hoc questions, and offering targeted feedback between live sessions.
Ideal Candidate
- 5+ years of writing experience authoring PSURs or PBRERs for enterprise biotech and pharmaceutical organizations - experience with PSURs / PBRERs should be recent.
- Big Pharma experience is required.
- Immunology, Dermatology, and/or Medical Device experience preferred.
- This is a micro-engagement. The selected consultant should expect 1-2 hours in TOTAL. The client is looking for one expert to advise/provide insights/Q&A in a one or two 1 hour virtual meetings with the team. Clora will process payment to the selected consultant immediately following a Client-approved billable activity, which may include meetings and meeting preparations.
Skills
Functional Areas
Medical Writing
*Must have
Therapeutic Areas
Dermatology / Plastic Surgery
Allergy / Immunology
Product Technologies
Device
Development Phases
I/Exploratory
II/Proof of Concept
III/Pivotal
Regulatory Pathways
IND