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Legal Specialist, Clinical Development Legal


New York, NY
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Job Details


The Clinical Development Legal group develops and maintains contract templates for a variety of clinical development transactions, including clinical study agreements, vendor agreements, and consultant agreements, and guidance and other instructional documents relating to the use of these templates. The group also manages templates relating to other types of contractual arrangements, such as investigator initiated research and clinical research collaborations, as well as related documents such as informed consent document templates, letters of authorization and data access requests.

The person in this position will serve as the primary point of contact for maintaining the template library for Clinical Development Legal, and will have responsibility for supporting template management on a global basis. The person in this position will also lead the effort to revamp the current template management process, to identify software options and incorporate a technological, automated process for template updates.

This position reports to the Senior Corporate Counsel, Quality, Sponsor Oversight & Operations, who leads the Legal Operations team. The preference is to have this role based in Pfizer's New York headquarters office. Consideration will be given to candidates who could instead be based in Pfizer's Groton, Connecticut or Cambridge, Massachusetts offices; however, the role would require some travel to New York headquarters during an initial training period.


+ Manage template library for Clinical Development Legal and the supporting client/contracting groups. This will involve:

+ Keeping the template library organized and accessible,

+ Recommending, testing, and using software tools to maintain the template library

+ Coordinating updates to specific contract provisions to ensure they are incorporated promptly into all applicable templates

+ Liaising with colleagues in Clinical Development Legal and other legal groups (e.g. Global Trade Controls, Privacy, Risk Management) and committees on a regular basis to ensure templates remain current, and to provide feedback on template use

+ Liaising with colleagues and contractors negotiating with third parties regarding access to templates, and feedback and improvements on template management

+ In conjunction with subject matter experts, managing the process for maintaining and updating contract or informed consent document template provisions that fall within Clinical Development Legal's area of responsibility

+ Leading the effort to bring a software or other technology solution to update and revamp the process for template management

+ Facilitating updates to guidance and other instructional documents.

+ Assist other legal specialists with questions from client/contracting groups that are escalated to Clinical Development Legal for review

+ Assist with funding requests, conflict of interest assessments, business rationale forms and similar client service matters

+ Providing ad hoc legal support on special projects as needed


+ Excellent academic qualifications including Bachelor's Degree or equivalent

+ Experience with and knowledge of template management software products and capabilities is preferred but not required

+ Minimum of 3 years' experience in a role supporting clinical trials at a sponsor company, CRO, research institution or clinical trial site

+ Experience with any or all of the following preferred but not required: outsourcing transactions, FDA regulatory compliance, Good Clinical Practice (GCP), international privacy law requirements

+ Excellent organizational, time management and work prioritization skills

+ Ability to track activities and provide detailed reports, as needed

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

+ Accountability, sound judgment, and the ability to take ownership of an issue


As noted above, the preference is to have this role based in Pfizer's New York headquarters office. Consideration will be given to candidates who could instead be based in Pfizer's Groton, Connecticut or Cambridge, Massachusetts offices; however, the role would require some travel to New York headquarters during an initial training period.

**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: January 24, 2018** Additional Location Information: Groton, CT., Cambridge MA.Eligible for Employee Referral Bonus

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