Danielle Duva Email & Phone Number

I have 20 years of experience in the pharmaceutical industry. I have experience working in several different areas of the pharmaceutical industry. I am currently working for a rare disease biotech company in Scientific Medical Writing, as a lead editor in the Regulatory Affairs Department. I edit all regulatory documents that come into Regulatory Affairs that will be submitted to the FDA and other world health organization’s globally. Since working in this role, I have been exposed to working in several different therapeutic areas such as Oncology, Gene Therapy, Genetic Disorders, Virology, and Nonsense Mutation.Prior to working for my current company, I worked for another biotech company in Oncology for almost 15 years. I was a Senior Specialist in Global Scientific Communications for publications for 8 years. I have experience with abstract/manuscript submissions as well as congress prep. I have many years’ experience with interacting with outsourced vendors and handing deliverables that have been outsourced to externals. I have experience with interacting with HCPs, metrics updating/planning and ensured that publications meet their deadlines. I have a vast knowledge and had been designated as the departments SME for the RTP (reimbursement to presenters) Process for US and OUS HCPs. I also would edit when needed. I have experience with QR codes/poster going to congresses. Prior to working in publications, I assisted, Managers, Senior Medical Writers and Medical Writers in the preparation of clinical documentation for regulatory submissions. I helped developed and implement ideas to improve documentation processes, including establishing report templates and guidelines. I provided data entry support for narratives and CSR in-text tables, as needed. I have experience in compiling files, reviewing, and assembling supportive documentation for CSR appendices in Documentum and provide CSR publishing support in Acrobat. I created and maintained trackers for narratives, review comments, and appendices. While also providing administrative support for the medical writing team.Before joining the Medical Writing Department, I had 8 years of experience in QA Document Control in Clinical and Commercial Manufacturing in document archival and retention, prepared, issue, route, track documentation packages throughout review and approval cycle, Issue & track logbooks, and batch records. I have assisted and have years of experience in FDA audits and inspections.

Listed skills include Validation, Regulatory Submissions, Lifesciences, Medical Writing, and 17 others.

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  Stockton University

  Psychology