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Job Details

Senior Corporate Counsel Clinical Development Legal

Company name
Pfizer Inc

Location
New York City, NY

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This position will provide legal support to the Clinical Development Legal (CD Legal) team on matters relating to clinical research collaborations, registry research, clinical data transfer, and other clinical development transactions. This position will also focus on legal requirements applicable to the use of digital approaches and social media in clinical trials, as well as other clinical trial innovation matters. The position will primarily support Pfizer’s Global Product Development (GPD) organization, responsible for clinical development, clinical trial conduct, and oversight of vendors developing mobile applications and other digital tools for use in clinical research. This role will also work on digital health initiatives across Pfizer, including Worldwide Research and Development (WRD), Business Technology (BT), Strategy and Commercial Operations (StratCo), Medical and Corporate Affairs. This role will report to an Assistant General Counsel and have a dotted line relationship to a Senior Corporate Counsel on the Clinical Development Legal team, supporting Pfizer clinical trial activities worldwide. Duties will also include ad hoc project work and other support as needed.

Role Responsibilities

Provide regulatory compliance advice to the Clinical Innovation team within Global Product Development, the Patient Engagement team within the Medical division and other groups in Pfizer involved in clinical innovation activities.

Assist with the development and implementation of digital and data initiatives and provide transactional support for Pfizer-supported clinical trials globally, such as mobile applications, use of social media for subject recruitment, electronic informed consent (eConsent), and integration of electronic medical records and clinical trial records (eSource).

Support GPD, and other stakeholders within Medical, Business Development and other stakeholders with respect to diligence, initiation, negotiation and execution of transactions, consulting with subject matter experts as needed, including agreements related to clinical innovation initiatives.

Assist with the development and implementation of digital and data initiatives and provide transactional support for Pfizer-supported clinical trials globally, such as mobile applications, use of social media for subject recruitment, electronic informed consent (eConsent), and integration of electronic medical records and clinical trial records (eSource).

Communicate regularly with Clinical Development Legal and other attorneys (including country/regional, privacy, and regulatory counsel) to ensure consistent legal support on relevant issues across the Pfizer portfolio worldwide.

Advise clinical study teams overseeing trials with digital tools in specific countries/regions.

Develop and support implementation of relevant policy and guideline updates.

Lead efforts to understand regulatory frameworks and local requirements for use of eConsent and medical software that may be regulated as software medical device changes in laws impacting clinical trials globally.

Implement updates to various agreement templates, related guidance and other instructional documents, as needed.

Provide subject matter expertise, and legal support and guidance on the development and application of standard operating procedures (SOPs) and related supporting procedural documents.

Provide ad hoc legal support on special projects as needed

Qualifications

Excellent academic credentials including a qualifying law degree.

Admitted to practice law and member in good standing in the relevant jurisdiction.

10+ years legal experience in the pharmaceutical or biotech industry, with substantial transactional experience, grounding in clinical development legal issues preferably including advice re Good Clinical Practice (GCP) and FDA/other biopharma regulatory compliance.

Strong interest in, and commitment to, the legal subject matters relevant to this role.

Excellent drafting and negotiation skills, with an eye for detail combined with pragmatism and sound judgment.

Excellent research, writing, counselling and communication skills and a client-service orientation.

Ability to work independently, as a team member, and across the organization.

Ability to manage a busy and diverse workload, and quickly and proactively identify and analyze potential legal issues.

Accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Other Job Details:

Last Date to Apply for Job:

June 26, 2018

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Company info

Pfizer Inc
Website : http://www.pfizer.com

Company Profile
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

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