Jane C.

• Responsible for the Writing, Editing and Formatting of Nonclinical Reports for an Oncology product • Created a Nonclinical template for future reports

• Responsible for editing/formatting the Pre-IND Package and Briefing Book for an Oncology submission

Medical Writer Consultant for the Immunology Group at Janssen through Business Talent Group • Responsible to the Johnson & Johnson Immunology team to support projects focused on coordinating and shaping content for training modules to be delivered to newly hired physicians, scientists, and clinical scientists, specifically within their Immunology therapeutic area. • Responsible to both lead and support the creation and execution of content for individual training modules and act as a liaison between internal stakeholders to drive the development and dissemination of these modules.

- Responsible for writing the Protocol Synopsis and Briefing Book for a new indication for a cancer product - Responsible for reviewing/editing the company Style Guide

- Responsible for reviewing/writing/editing/updating/formatting portions of two US approved NDA gastrointestinal products for submission to Canadian Health Authorities (CTD Module 2 Summaries, Briefing Books, Pre-SNDS meeting materials, slide deck and meeting minutes, product monograph – English and French versions, orphan drug designation documents) and completed several Literature searches - Participated in the successful Health Canada submission of an IBS-D product - Participated in several Briefing Books and Orphan Drug Designation documents - Responsible for Content Tracking Logs - QC review of all hyperlinks for submission documents - Updated Investigator Brochures - Formatted and reviewed several protocols and study reports - Managed submission content in Documentum - Created a Style Guide for use with all regulatory documents - Assisted Clinical and Clinical Pharmacology with documents

- Responsible for Writing and QC of Serious Adverse Event Oncology Narratives (Melanoma/NSCLC) - Responsible for QC review of several documents (2.7.3 Efficacy Summary, CSR, ISS, ISE)

- Responsible for writing/reviewing/QC of sections of Periodic Benefit Risk Evaluation Reports, Development Safety Update Reports and Clinical Overviews - Writing and QC of Serious Adverse Event Narratives and the corresponding text in Periodic Benefit Risk Evaluation Reports

Senior Medical Writer, Clinical / Nonclinical Writing, providing all medical writing support for two products: 1) Gastrointestinal product, Phase 3: - Authoring/editing/quality control review of Clinical and Nonclinical Study Reports, Protocol, Protocol Amendments, Clinical Development Plans, Population PK report, Pediatric Investigational Plan, White paper, Investigator Brochure, Annual Reports, Statistical Analysis Plan, Data Integration Plan, Abstracts, CTD Overview Modules, Issue Resolution Meeting, Responses to Health Authorities 2) Hypoparathyroid product: - Authoring/editing/quality control review of IND, Protocol, Protocol Amendments, Informed Consent, Patient Information, Instructions for Use, FDA responses, Investigator Brochure, Annual Reports As the Sole Medical Writer for NPS: - Provided reviewing/writing/formatting support for Research and Development, Regulatory Affairs and Marketing for NPS and their partner Nycomed - Provided and supervised quality control review of regulatory documents - Supported Regulatory in submissions to FDA, Health Canada and European markets - Acted as one of two System Administrators in the implementation and training of MasterControl [an electronic document management system (EDMS)] and participated in the selection of NextDocs EDMS for the company - Worked with Regulatory to bring in Sage Templates for eCTD compliance - Reviewed work of other writers (in-house and contract) for accuracy, quality, focus, and adherence to format and style requirements - Trained and guided other writers (in-house or contract) in company policies and procedures related to document preparation - Worked with project teams, corporate partners, CROs, vendors and consultants to facilitate effective interactions and information exchange/communication - Managed in-house project teams, our partner Nycomed and the medical writing consultant to transition responsibilities to the CRO when Medical Writing was outsourced

Contract Medical Writer Parkinson's Disease eCTD and Oncology INDs Clinical (all products): - Responsible for QC review, writing/editing of portions of Clinical Study Reports, Protocols and templates - Responsible for the Investigator Brochure, Briefing Document - Initiated Clinical Tracking Report for the Medical Writing Group - Provided Abstracts for Publication, Work Instructions, SOPs, Literature searches - Reviewed work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and style requirements Nonclinical (Parkinson’s Disease product): - Responsible for the Review, Writing and Editing of Pharmacology, Toxicology, Pharmacokinetic modules - Responsible for the Overview and Introductory sections of eCTD NDA - Responsible for Annual Reports, Investigator Brochure, FDA response, Briefing Document, Nonclinical Reports, Abstracts and Posters for Publication - Developed Nonclinical eCTD Templates

Responsible for the following: - Writing and QC of Patient Oncology Narratives for Serious Adverse Events - Quality Control review of Clinical Study Reports - Summarizing Publications for the ISS - Protocol template review - Investigator Brochure update - Quality Control review of Tables and Listings - Reviewed work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and style requirements