Senior Corporate Counsel – Regulatory
INC Research - Raleigh, NC

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Job Summary

Provide legal and regulatory support on a broad range of activities as a member of growing legal team and a full service Phase I-IV clinical research organization (CRO) responsible for conducting clinical development programs worldwide. This role includes support for INC’s regulatory functions, as well as general advice and counsel on risk mitigation internationally. The role will also provide legal support to therapeutic business units and support functions worldwide.

Core Responsibilities

1.Support INC Research’s regulatory compliance, liaise with in-country regulatory channels to develop internal and external analysis and guidance regarding regulatory issues and oversight.

2.Provide reporting to the General Counsel and Executive Management regarding regulatory compliance with federal, state, and international guidelines related to clinical trials, including international selection of investigators, site monitoring, patient recruitment, safety surveillance and reporting, ethics committees/IRB’s and site audits.

3.Provide advice and counsel to INC Research’s therapeutic business units and platform functions regarding global regulatory compliance and risk mitigation generally.

4.Provide training and education globally regarding legal updates, best practices, and risk mitigation with particular focus on regulatory matters and risk mitigation.

5.Support internal legal team (M&A) regarding regulatory diligence and analysis and provide support for INC’s commercial contracting on matters of regulatory significance.

6.Provide guidance and strategy related to the Sunshine Act and other similar regulatory requirements.

7.Manage claims and litigation matters.

Other Responsibilities:
Perform other work-related duties as assigned.

Skills & Attributes

Six (6) to Twelve (12) years of regulatory and risk mitigation experience preferred, with a minimumm of 4 years required, related to clinical trials, including significant experience on behalf of a CRO. Strong understanding of clinical trials, including selection of investigators, site monitoring, patient recruitment, safety suerveillance and reporting, ethics committees/IRB’s and site audits. Top credentials, including significant experience in private practice and in-house strongly preferred. Superior strategic, written and organizational skills with the ability to multi-task under aggressive deadlines and the ability to work with various stakeholders worldwide. JD in good standing and admitted to practice in at least one state. Position will be based at INC Research headquarters in Raleigh, NC.

Physical Requirements: Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

INC Research is an EEO, M/F/D/V and a drug-free workplace. INC Research voluntarily participates in the federal E-Verify work authorization program.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to jobs@incresearch.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.

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INC Research is not fazed by the four phases a new drug has to go through to get from idea stage to commericial adoption. The contract...