Darshan Kulkarni Email & Phone Number

Jenkintown, Pa, Us

Helping life science companies and their service providers help improve sales, address patient needs and healthcare provider concerns by complying with laws and regulations by providing the following services: A. Provide General Counsel/ Chief Compliance Officer services to life sciences companies, CROs, SMOs, and advertising companies with risk oversight by complying with a variety of legal, regulatory, and compliance issues including the Code of Federal Regulations, the False Claims Act, Anti-Kickback Law, HIPAA, Stark Laws, Foreign Corrupt Practices Act, etc. by adhering to the requirements suggested by the OIG, DOJ, US Attorney's Offices, the FDA, and other governmental and non-governmental organizations. B. Clinical trial negotiation services for, and against, investigators, CROs, and sponsors.a. Formulation of letters of indemnification, b. Negotiation of payment schedules,c. Budget determination, d. formulation and negotiation of master services agreements.C. Assuring Quality, Regulatory and Legal Servicesa. Review, presentation, and response to 483s, Warning Letters, and other titled and untitled FDA letters,b. Systematic implementation and training of a comprehensive SOP program,c. Review of promotional materials and actions of sales and scientific staff to ensure legal, regulatory, and medical compliance,d. Conducting product recalls.D. Apply for state and federal licensure with boards of pharmacy, attorney general's offices, etc. for manufacturing and distribution facilities.E. Building compliance systems within companies.

Philadelphia, Pa, Us

Helping develop the next generation of regulatory professionals who understand not just what the regulations are, but why they are interpreted as they are - so that one can effectively navigate not just the current regulatory schema, but the potential future. I have taught the basics of FDA regulatory law and am developing coursework in several more course offerings.

Helping improve payor provider relationships by using optimized nudging techniques by: 1. Providing legal and regulatory advice or consultation to the Company and reviewing and recommending institutional policies, procedures, guidelines and other documents as needed.2. Reducing the likelihood for inappropriate, unnecessary or costly institutional liability in contractual agreements and terms or business arrangements by reviewing and/or preparing contracts and other legal documents for execution by or on behalf of the Company.3. Representing the Company during administrative or judicial proceedings by serving as the General Counsel, advising in the representation, or overseeing the representation of the Company as well as administrative and judicial bodies of the United States and the commonwealth of Pennsylvania.4. Remaining competent and current through self-directed professional reading, developing professional contacts with colleagues, attending professional development courses, and attending training and/or courses as directed.5. Contributing to the overall success of the Company by performing other duties and responsibilities as assigned by the Company’s representatives.6. Assisting with compliance activities including obtaining HITRUST certification as necessary to comply with PCI, GDPR, HITECH, HIPAA etc.

Philadelphia, Pa, Us

- Teach courses on Regulatory Documentation Process, Law and Ethics in Biomedical Writing, and Promotion of Biomedical Products.- Respond to student inquiries and discussions on asynchronous discussion board.- Host teleconferences.- Read and grade student papers.

Radnor, Pennsylvania, Us

Work with counsel and C-Suite to proactively monitor, analyze, interpret and communicate emerging global regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within disease therapy areas.Leads development of position statements, white papers on emerging regulatory issues with cross regional impact as well as articles with broad regulatory perspective for internal publications.Leads Regulatory Intelligence Activities for assigned therapeutic areas and service lines, including queries, regulatory environment sections of product specific regulatory strategy documents and broader disease area strategy documents, and regular regulatory intelligence newsletters.Supports Business Development on select projects participating in due diligence and providing insight on the regulatory environment for potential acquisitions, VC and portfolio strategy and valuation.Develop regulatory and industry thought leadership about the future state of innovation and drive guidance through multiple stakeholder initiatives and cross industries for benefiting public health through introducing change and using and challenging precedent.Assist in global engagement with regulatory authorities including regulatory filings, meeting transparency goals, privacy considerations and intellectual property needs including by meeting patient centricity standards.

Philadelphia, Pa, Us

Serve on the hospital's Compliance CommitteeAudit the Hospital's pharmacy's billing to Medicare/Medicaid.Perform appropriate corrective and preventative measures in light of audits performed.

Philadelphia, Pa, Us

- Corporate counsel services, including negotiating and consummating international licensing and financing transactions, dealing with US and non-US governmental entities, and creating and negotiating master services agreements.- QA/RA Legal Services:Review, presentation, and response to 483s, Warning Letters, and other titled and untitled FDA letters.Systematic implementation of a comprehensive SOP program.- Apply for state and federal licensure with boards of pharmacy, attorney general's offices, etc. for manufacturing and distribution facilities.- Conduct supplier audits.

- Study and analyze scientific or technical documents, including previously published patent documents, to assess in what ways an invention is new and innovative.- Write detailed descriptions of inventions in precise legal terms (patent drafts), which form the basis for patents to be granted by patent offices in various parts of the world.- Suggest modifications or extensions to the definition of the invention.- Prepare responses to reports from patent examiners.- Ensure application and renewal deadlines are observed.

- Assist with discovery disputes.- Schedule settlement conferences and trials. - Draft trial briefs and opinions both short and long.- Maintain correspondence and contact with attorneys and witnesses.

Philadelphia, Pa, Us

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Philadelphia, Pennsylvania, Us

Philadelphia, Pa, Us

- Risk management assessments, as well as ensure compliance with local, state, and federal guidelines regarding emergency and security. - Serve as a liaison with local law enforcement to assist investigations of accidents, thefts, and property loss.- Hire, train, and coordinate work schedules of all security personnel to ensure a secure environment.

Baltimore, Md, Us

- Implement instructional activities that contribute to a climate where students are actively engaged in meaningful learning experiences. - Identify, select, and modify instructional resources to meet the needs of the students with varying backgrounds, learning styles, and special needs.- Assist in assessing changing curricular needs and offer plans for improvement.- Maintain effective and efficient record keeping procedures.- Provide a positive environment in which students are encouraged to be actively engaged in the learning process.- Communicate effectively, both orally and in writing, with students, parents, and other professionals on a regular basis.- Collaborate with peers to enhance the instructional environment.- Model professional and ethical standards when dealing with students, parents, peers, and the community.- Ensure that student growth and achievement is continuous and appropriate for the age group, subject area, and/or program classification.- Establish and maintain cooperative working relationships with students, parents, and schools.- Assume responsibility for meeting course and school-wide student performance goals.- Demonstrate gains in student performance.- Participate in training and presentations about online teaching.- Meet professional obligations through efficient work habits such as: meeting deadlines, honoring schedules, and coordinating.- Perform other duties and responsibilities as assigned by the supervisor.

Ms In Qa/Ra, Pharmaceutical Quality Assurance Regulatory Affairs

Fellowship, Interprofessional Geriatric Care

Science Of Pharmaceutical Compounding - Training Certificate, Pharmacy - Compounding

Jd, Law

Pharm.D, Pharmacy, Psychology, Computers, Communication

Associates, General Studies

First And Second Years Of Junior College