• Submission lead (Module 5) for common technical document (CTD) submissions, including a new drug application (NDA) sent to the US FDA and co-leader for a Chinese NDA sent to PMDA• Prepares, contributes to, and reviews high-quality clinical and regulatory documents, including integrated CTD summaries (clinical overview [CO], summary of efficacy [SCE], summary of safety [SCS], integrated summary of efficacy [ISE], and integrated summary of safety [ISS]) for regulatory submissions, responses to questions from health authorities, briefing books for health authority meetings, clinical protocols, protocol amendments, investigator brochures (IBs), clinical study reports (CSRs), and other documents such as statistical analysis plans (SAPs), breakthrough designation requests, and initial pediatric study plans (iPSPs)• Reviews documents as lead clinical writer, ensuring that execution and delivery are consistent with team and company standards and objectives• Supervises projects, identifies resource needs, and contributes to planning timelines; ensures timelines are met and that changes are communicated appropriately• Supervises contractors• Participates actively in project teams, represents Medical Writing in interactions with other functional groups, provides project updates and works with other groups to resolve issues; reviews tables, figures, and listings (TFLs)• Owner of the Allergan style guide• Represents Medical Writing in template, job aid, and standard operating procedure (SOP) update teams; designated subject matter expert (SME) in protocol and IB templates and preparation• Member of two TransCelerate initiative teams: common protocol template (CPT)/clinical content and reuse (CC&R) and eConsent• Participates in other Medical Writing initiatives and process improvements• Participates in selection and training of new staff

Writes, edits, and/or contributes to medical writing documents of various complexity, including protocols, investigator brochures, ICFs, CSRs, CTD components, manuscripts, and specialized projects such as briefing documents, fast track, and orphan drug applicationsProvides expert guidance in medical writing issues including content, format, and project managementSpecializes in regulatory submissions (primarily FDA, as well as EMA, with some experience in rest of world submissions)Also experienced with toxicology and CMC writing

Wrote complex documents for regulatory submissions, including CTD summary documents, CSRs, IBs, and ad hoc requestsHad primary responsibility for managing electronic review cycles of all clinical documents for my productsManaged medical writing needs for several large projects, including determining the need for contractors and managing their workTrained and mentored junior staff and contractorsContributed to project and departmental meetings as the primary contributor for my function and/or product and kept senior management informed about important developmentsMaintained tracking logs of important departmental and project issuesSubstantial contributor to company-wide projects critical to medical writing, such as electronic case report form design, processes for integrating clinical and pharmacovigilance data for patient narratives, and harmonization/globalization of templates

• Lead writer for IND submissions, including clinical and nonclinical sections and both traditional and eCTD formats• Wrote and edited clinical study reports, protocols, investigator brochures, informed consent forms, package inserts, briefing documents, SAE narratives, other regulatory submissions, and manuscripts• Involved in proposals and bid defenses

• Lead writer for eNDA submission, including all clinical sections, package insert, safety updates, and summary documents• Lead writer for IND submissions, including clinical and nonclinical sections and both traditional and eCTD formats• Wrote and edited clinical study reports, protocols, investigator brochures, informed consent forms, package inserts, briefing documents, SAE narratives, other regulatory submissions, and manuscripts• Project manager for projects including data management, biostatistics, pharmacovigilance, medical monitoring, medical writing, and drug supply services; global project lead for one sponsor• Involved in proposals and bid defenses

• Wrote, edited, and compiled clinical study reports, protocols, SAE narratives, informed consent forms, and other documents• Designed and maintained templates and style guides

• Coordinated preclinical development projects for government clients• Wrote quarterly and annual progress reports• Prepared proposals; estimated costs; oversaw budgets and timelines• Wrote protocols and reports for toxicology, immunology, biochemistry, and pharmacokinetic studies in animals• Worked as part of a project team coordinating safety testing and IND submissions for HIV vaccine development

• Wrote and maintained SOPs, development reports, and protocols• Conducted tests of drug product purity, potency, and protein concentration• Created, organized, and maintained databases of department documents and data• Assisted in development and optimization of ELISA and Western blot assays