Research Specialist

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Research Specialist
The candidate will conduct FDA and Healthcare regulatory research under attorney supervision. Research FDA Guidance’s (and 21 CFR) to assist in elucidate FDA’s standing on diverse regulatory or statutory issues. Research FDA regulations and compile draft memos and presentations with the information. Conduct research and due diligence regarding expert witnesses under attorney supervision. Assist with material preparation for witness interviews, depositions, hearings and/or client meetings. Search, identify and/or research drugs and medical devices (or their manufacturers) on FDA databases, assess potential FDA classification of products, as well as alternatives for FDA classification. Analyze and research products, identify potential pathways for market clearance or approval, specifically for medical devices.  Research pharmaceutical/drug/biologic/medical device regulations. Conduct analyses based on specific scenarios to assess which regulations might be applicable. Review regulatory filings for errors and potential issues. When needed, format and adapt the filings, as well as managing the submissions.  Project manage submission processes for regulatory filings. Prepare summaries of company profiles, bios, news research as well as regulatory compliance and litigation reports. Assist with regulatory due diligence for transactions, including mergers and acquisitions, asset purchases and offerings under attorney supervision. Review contracts and agreements to obtain the information requested by the attorney. Compile and analyze legal, corporate, and general resources and communicate findings in a clear and concise manner. Attend town halls, board meetings, and webinars and take comprehensive notes and provide them to attorneys. Contact and communicate with specific FDA Offices to request guidance or information about regulations/ their applicability. Be familiar with FDA marketing regulations, conduct analyses of marketing materials and flag potential violations under attorney supervision. Be familiar with Sunshine Act and Anti-Kickback statute regulations, research FDA Open Payments website for information on specific healthcare providers or manufacturers. Conduct reviews of regulatory filings for drugs and medical devices for further information about the product (includes 510(k)s, 10-Qs, and similar). Review and prioritize all client and other communications including emails and phone calls for client meetings and client pitches. Produce, edit, and proof legal documents, excel worksheets and PowerPoint presentations. General follow-up to assist attorneys in effectively meeting deadlines and commitments. Develop positive relationships with attorneys and staff and liaise with multiple departments to communicate the needs/plans of the practice group; ensure Firm policies and procedures are communicated and followed. Ensure timely service and filing of legal motions, briefs, and other pleadings. Effectively communicate with clients, including CEOs and General Counsels. Assist with material preparation for witness interviews, depositions, hearings and/or client meetings. Prepare and proofread Draft Pleadings under the supervision of attorneys. Draft correspondence and coordinate meetings and conferences between firm lawyers, clients, and additional parties. Other duties may be assigned to fully meet the requirements of the position.

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