Ted Orff Email & Phone Number

San Diego Metropolitan Area

San Diego, California, United States

• Act as a subject matter expert (SME) by maintaining a thorough understanding of national (e.g., Food and Drug Administration [FDA]) and international (e.g., European Medicines Agency [EMA]), regulations and guidance (e.g., International Council for Harmonisation [ICH]) pertaining to medical and scientific writing.• Analyze clinical data and independently author various clinical and scientific document types to meet customer needs and regulatory requirements using appropriate templates and… Show more • Act as a subject matter expert (SME) by maintaining a thorough understanding of national (e.g., Food and Drug Administration [FDA]) and international (e.g., European Medicines Agency [EMA]), regulations and guidance (e.g., International Council for Harmonisation [ICH]) pertaining to medical and scientific writing.• Analyze clinical data and independently author various clinical and scientific document types to meet customer needs and regulatory requirements using appropriate templates and toolbars.• Author protocol amendments (global and country-specific), Informed Consent Forms (ICFs), addendum clinical study reports (CSRs) and CSR synopses according to clinical trial transparency standards, lean writing principles, and Good Documentation Practice (GDP).• Collaborate cross-functionally for the completion of documents using document sharing (e.g., SharePoint, Teams), review (e.g., PleaseReview), and management (e.g., Veeva) tools.• Function as study team Medical Writing lead, capable of managing documentation tasks with flexibility to shifting timelines and priorities.• Communicate with therapeutic area team members for clinical and scientific input on regulatory documentation.• Apply QC processes related to clinical and scientific reporting.• Identify, develop, and implement new processes or efficiencies.• Supply customer service to mid-size pharmaceutical clients as a full-time equivalent (FTE).• Schedule, lead, and manage client meetings for effective resolutions.• Recognize and mitigate project risks, including assessing process gaps.• Provide guidance and mentorship to others within MMS and to external clients as necessary. Show less

Swiftwater, Pennsylvania, United States

• As subject matter expert (SME), lead analytical method development, qualification, validation, implementation, training and transfer activities of compendial (e.g., European pharmacopeia [EP]) and novel analytical assays (e.g., Polymerase Chain Reaction [PCR, Applied Biosystems 2100], next-generation sequencing [NGS, Illumina MiSeq], immunoassays, enzymatic assays [Molecular Devices SpectraMax Paradigm]) including operational and performance qualification (OQ/PQ) of related machinery, to meet… Show more • As subject matter expert (SME), lead analytical method development, qualification, validation, implementation, training and transfer activities of compendial (e.g., European pharmacopeia [EP]) and novel analytical assays (e.g., Polymerase Chain Reaction [PCR, Applied Biosystems 2100], next-generation sequencing [NGS, Illumina MiSeq], immunoassays, enzymatic assays [Molecular Devices SpectraMax Paradigm]) including operational and performance qualification (OQ/PQ) of related machinery, to meet US and international testing requirements.• Anticipate and advance future analytical requirements to address projected needs and mature or modify existing technology for application towards new vaccines and provide feedback from the results of those assessments to the development team for product enhancements.• Initiate, author, assess, review, execute, track and manage protocols, reports, standard operating procedures (SOPs) and standard work instructions (SWIs) using appropriate software such as Microsoft Office, Softmax, AccuSEQ, and LIMS.• Apply and adhere to health, safety, and environment (HSE) corporate best practices and national guidelines (e.g., Occupational Health and Safety Administration [OSHA], Department of Environmental Protection [DEP]).• Mentor, train, and guide interns, associates, and contractors on aspects of analytical method development Show less

Eastern Pennsylvania

• Support corporate objectives through cross-functional teams to assure the safety, identity, strength, purity and quality of inactivated (e.g., influenza) and live-attenuated (e.g., yellow fever) viral vaccines.• Interact with national (e.g., Centers for Disease Control [CDC], National Institute of Health [NIH]) and international (e.g., National Institute for Biological Standards and Control [NIBSC]) infectious disease monitoring and control agencies.• Lead the multifunctional… Show more • Support corporate objectives through cross-functional teams to assure the safety, identity, strength, purity and quality of inactivated (e.g., influenza) and live-attenuated (e.g., yellow fever) viral vaccines.• Interact with national (e.g., Centers for Disease Control [CDC], National Institute of Health [NIH]) and international (e.g., National Institute for Biological Standards and Control [NIBSC]) infectious disease monitoring and control agencies.• Lead the multifunctional manufacturing (seed, drug substance, formulation, filling, inspection, labeling, packaging and shipping drug product) of experimental influenza vaccines in support of influenza pandemic readiness activities in agreement with US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA)• Advance vaccine technology through process improvements (including custom fabrication) in accordance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).• Initiate, author, assess, review, execute, track and manage change controls (CC), deviations, protocols, and reports using appropriate software such as Microsoft Office, Trackwise, Phenix.• Apply and adhere to health, safety, and environment (HSE) corporate best practices and national guidelines (e.g., US Department of Agriculture [USDA]). Show less

• prepare preclinical documentation such as pharmacology, pharmacogenomics, pharmacokinetics, cell biology, and biochemistry reports, as well as clinical communications such as Phase 1, 2, and 3 clinical study reports (CSRs), Investigator’s Brochures (IBs), Investigational New Drug (IND) submissions in electronic Common Technical Document (eCTD) format, while maintaining pharmaceutical industry standard operating procedure guidelines in an electronic repository• process documentation using… Show more • prepare preclinical documentation such as pharmacology, pharmacogenomics, pharmacokinetics, cell biology, and biochemistry reports, as well as clinical communications such as Phase 1, 2, and 3 clinical study reports (CSRs), Investigator’s Brochures (IBs), Investigational New Drug (IND) submissions in electronic Common Technical Document (eCTD) format, while maintaining pharmaceutical industry standard operating procedure guidelines in an electronic repository• process documentation using Microsoft (MS) Word, creating graphs and charts in MS Excel and SigmaPlot, creating slides in MS Powerpoint, and integrating this information into documents meeting International Conference on Harmonisation (ICH) guidelines and international regulatory agency requirements• mentor and supervise part-time writers in the completion of clinical and scientific documentation. Show less

• Prepare regulatory documentation such as Phase 1, 2, and 3 CSRs, Integrated Summary of Safety Reports (ISSs) and CTDs, according to FDA and ICH guidelines for content, accuracy, and timeliness while maintaining pharmaceutical industry standard operating procedure (SOP) guidelines

• Prepare regulatory documentation such as Phase 3 CSRs, IBs and IB updates, Protocols and Protocol amendments, safety summary, and patient narratives, according to FDA and ICH guidelines for content, accuracy, and timeliness while maintaining pharmaceutical industry SOP guidelines

• Prepare regulatory documentation such as Phase 1/2, and 3 CSRs, Investigational New Drug Annual Reports (INDARs) and clarifaxes, according to FDA and ICH guidelines for content, accuracy, and timeliness while maintaining pharmaceutical industry SOP guidelines.

• Examination of the stress response mechanisms of Borrelia burgdorferi, the causative agent of Lyme disease. B. burgdorferi has developed the unique ability to survive in both ticks and animals• Current techniques in molecular biology were employed to discern the ability of this bacterium to survive in these two diverse niches.

Phd, Virology, Microbiology, Vaccine Design

Dissertation research focused on influenza type B M1 (matrix protein). A protocol for the creation of high yield reassortants was.

Bs, Microbiology

Minor: Political Science Certificate: Biotechnology