Roberta Driscoll- Weiss Email & Phone Number

United States

Basel, Baselstadt, Ch

Major accountabilities: in close coordination with senior business leaders to drive robust implementation of ERC activities by upskilling associate understanding and engagement in ethics and compliance activities through policy development, training, and advice. Specifically:• Shape and clarify R&D research ethics policy;• Drive consistency to ensure consistent strategies to integrate clear and actionable ERC guidance on key risk issues into R&D operations and training strategies to support execution of function-specific and cross-functional strategies in compliance with applicable policies and procedures;• Effectively engage and collaborate with R&D leadership teams to ensure they have a holistic view of research ethics principles and regulations to implement strategies to address key or emerging risks.• Proactively monitor evolving US healthcare environment, enforcement trends and compliance programs of other pharmaceutical, biotech and medical device companies, analyze with deep understanding of research ethics and compliance strategies and applicable ERC policies to identify and share insights within ERC.• Be a knowledge/ subject matter expert related to research ethics and compliance policies and procedures and how they apply to associates’ roles and responsibilities throughout the R&D organization.• Engage with leaders and associates to develop trusted relationships with associates of all levels to promote a SpeakUp culture;• Collaborate with R&D teams to strengthen a positive culture towards compliance and ethical decision making as an integral part of R&D activities.• Ensure that clear and actionable ERC guidance is provided to relevant stakeholders;• Serve as Novartis R&D ERC representative with pharmaceutical organizations (e.g. IFPMA) to assist with broad policy and position directives.

Specializing in appellate advocacy, civil litigation, healthcare compliance and health care access

Boston, Ma, Us

Manages Conflicts of Interest Program:* Establishing policies to identify and prevent individual and institutional conflicts of interest; * Evaluating financial disclosures to identify potential conflicts of interest, and where necessary, drafting, implementing and monitoring compliance with management plans;* Creating training materials, and conducting training programs for faculty and administrative staff;* Establishing enhanced practices for ensuring policy compliance through collaboration with the Institutional Review Board, Technology Transfer office, and the Office of General Counsel.* Assisting in the creation of the online COI disclosure process;* Working collaboratively with faculty and staff, both within the Institute and across affiliated institutions;* Institutional Contracts Review: primarily responsible for drafting and negotiating all contracts for services involving faculty and research staff with pharmaceutical industries, medical education companies, and academic institutions;Research Integrity Officer: responsible for investigating allegations of research misconduct and authorship disputes.

* Civil litigation: maintained a general legal practice, with an emphasis on civil litigation in the in the District, Juvenile, and Probate & Family court systems in child welfare, custody, and medical and mental health treatment matters;* Appellate advocacy: maintained a general appellate practice involving preparing and arguing post-trial matters before the Massachusetts Appeals Court and the Supreme Judicial Court of Massachusetts;* Guardian ad litem representation: provided recommendations and oversight to the Court system in child custody and medical treatment cases, and estate matters involving wills and trusts;* Mentoring: coached and mentored attorneys as part of the Commonwealth of Massachusetts Committee for Public Counsel Services training requirements;* Training: served as a professional presenter at continuing legal education and professional seminars in the areas of trial preparation and discovery, ethics, mediation and alternative dispute resolution;* Educational Advocacy: extensive experience as advocate for the provision of special education services, including appeals of service denials to the Board of Special Education Appeals;* Business management: solely responsible for business development, client relationship and case management, employee supervision, and interacting with vendors.

* Project Management: general oversight of all aspects of an array of epidemiologic studies related to communicable disease transmission, including preparing study protocols, preparing budgets, drafting job descriptions, hiring and training all necessary staff; and drafting all study data collection instruments;* Public Health research: researching and preparing funding proposals for submission to Federal agencies, private, and non-profit organizations to support research initiatives dealing with public health matters such as HIV/ AIDS, tuberculosis, and communicable disease prevention;* Management of city-wide childhood immunization program intended to centralize immunization records for children in Boston to ensure timely immunizations;* Preparation of project findings, abstracts, and manuscripts for submission for publication in Public Health journals, texts, and periodicals, including all mathematical and statistical analyses on collected study data; presented study findings at Public Health conferences, seminars, and meetings.

Masters Degree, Bioethics

Jd, Law

B.S., Psychology

Doctor Of Professional Studies, Bioethics And Health Policy

Education record