Erica Dankiewicz Email & Phone Number

Danbury, Connecticut, Us

Piscataway Township, New Jersey, Us

Pearl River, New York, Us

Pearl River, New York, Us

-Oversaw US medical information activities including management of the medical information call center and all aspects of medical information delivery (e.g. SRLs, FAQs and escalated inquiries).-Supported medical information activities for EU business partner where applicable.-Continued role as main medical reviewer of promotional and scientific materials.-Compiled and published regulatory submissions to the FDA using electronic publishing software and worked with third-party vendor as needed for EU/UK submissions.-Represented Regulatory Affairs on multidisciplinary teams, driving timelines and deliverables related to submission documents (e.g Technical File for MDD to MDR transition).-Assisted Regulatory project lead in projects including but not limited to labeling activities, annual device and establishment registrations, and product listings.

Pearl River, New York, Us

-Oversaw all activities for outsourced US medical information call center; including the review and approval of responses to escalated inquiries and maintenance of materials.-Continued role as lead medical reviewer by ensuring medical accuracy and fair balance of promotional and non-branded scientific materials, including podcasts, patient videos, websites, social media channels, and other digital platforms.-Authored SOPs on internal medical information operations and those regarding collaboration with outsourced call centers.-Joined Regulatory Affairs team in September 2021 and became responsible for regulatory submissions and operations.-Handled all technical aspects of regulatory submissions such as eCTD granularity, utilization of StartingPoint templates, document formatting/publishing, eCTD application location and lifecycle assignment.-Ensured timely submission of regulatory-compliant, quality documents by liaising with internal subject matter experts.-Archived all submissions and correspondences between Acorda, the FDA and any other health authority.-Supported department on any other tasks or initiatives, including but not limited to health authority inspections.

Pearl River, New York, Us

-Prepared outsourced call center for launch of new product by authoring standard response documents, training call center pharmacists and thereafter, responded to escalated inquiries.-Supervised team of three, including two Rutgers Fellows and one contracted Medical Information Specialist.-Collaborated with marketing colleagues as the primary medical reviewer, contributing to the preparation and launch of a new product.-Staffed medical information booths at domestic and international medical meetings.

Pearl River, New York, Us

-Researched and wrote standard response letters and other communications in response to unsolicited HCP, consumer, and field-based inquiries.-Ensured the accuracy of scientific content, including promotional materials, training programs, corporate communications, and specific medical documents, while adhering to relevant policies, procedures, and regulations.-Mentored Rutgers Pharmaceutical Industry Fellows participating in Acorda Medical Affairs Fellowship.

-Dispensed new and refill prescriptions in a timely and accurate manner-Counseled patients on medications and over the counter items to ensure optimal clinical outcomes-Communicated with third-party payers to resolve issues related to prescription claims processing

Stamford, Ct, Us

-Provided up-to-date, scientifically accurate, and balanced medical information in response to unsolicited inquiries live via call center or through written communications-Assisted in the development and revision of standard response documents used by in-house call center staff-Evaluated commonly used online drug information compendia to ensure publicly available HCP and consumer information was aligned with approved product labeling-Facilitated sales, product, and disease state training-Designed and launched medical information webpage, Ask Purdue Medical, with a goal of enhancing the user experience for HCPs and patients going there for answers to medical questions -Conducted medical review of promotional and non-branded scientific materials

Leverkusen, North Rhine-Westphalia, De

US Medical Affairs: Neurology/Hematology-Planned and organized national advisory boards by drafting agenda, presentations and discussion guide while networking with top tier key opinion leaders -Examined proposals for continuing medical education programs, grants, and investigator sponsored studies and provide recommendations based on clinical and strategic relevance-Provided feedback on company sponsored publications and coordinated review among key internal and external stakeholdersBusiness Development Strategy & Innovation (rotation) -Created guidance document on currently approved therapies, unmet medical needs, and analyst forecasts for a specific therapeutic area of interest to BayerRegulatory Affairs (rotation)-Evaluated promotional materials targeted to health care professionals and/or consumers to ensure compliance with regulatory guidelines-Analyzed enforcement letters from the Office of Prescription Drug Promotion and presented key findings to medical, regulatory and legal teams Health Economics and Outcomes Research (rotation) •Lead AMCP dossier update for a key neurology product. Revised dossier to meet AMCP 3.0 guidelines, provided relevant scientific data, reviewed content for medical accuracy, and obtained copyright permissions for figures and graphsMedical Communications-Provided verbal and written responses to unsolicited consumer and healthcare professional inquiries-Created, updated, and maintained standard response database of verbal and written responses for neurology/hematology products -Evaluated promotional materials to ensure medical accuracy and to ensure that all claims were supported by substantial evidence -Authored publication awareness reports evaluating new scientific data on multiple sclerosis and relevant company and competitor products

New Brunswick, Nj, Us

-Co-chief Fellow for the 2011-2012 class-Acted as co-coordinator of the Leadership for Pharmacy Professionals course by working with faculty and guest lecturers in the development of the course syllabus, lecture content and assignments-Lecturer for the Leadership for Pharmacy Professionals course-Guest lectured for the Pharmacy Practice Management course

-Maintained product literature database and medical content letters used in response to unsolicited requests-Reorganized and expanded use of quick reference guides; tool summarizing prescribing information for company and competitor products