Privacy Specialist - Operations

Job Profile Summary

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

Responsibilities

Essential Functions

•Acts as a Privacy Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;

•Competently writes regulatory, privacy, and/or technical documents with minimal review by senior staff;

•Establishes relationships with many customers; may meet face to face without rest of team to discuss privacy regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;

•Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;

•May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;

•May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;

•May write new privacy regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.

•May be involved in a Privacy Regulatory and/or IQVIA Initiative;

•Performs other tasks or assignments, as delegated by Regulatory management;

•May manage meetings with Regulatory Agencies;

•May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations;

•May support global regulatory, privacy, or technical initiatives or act as a regional representative on a cross-functional initiative;

•Performs other duties, as business needs require;

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires 3 - 5 years of prior relevant experience.

Knowledge

Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education

Bachelor's Degree

Degree in Lifescience or related discipline

Additional Work Experience

At least 3 years relevant experience

Skills and Abilities

Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;

Possesses a specific privacy regulatory or technical expertise. Sufficient knowledge of managing privacy regulatory projects, project deliverables on a time bound manner;

Expert in planning and delivering work on time keeping quality parameter in mind;

Knowledge of privacy regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies;

Good working knowledge of regional privacy regulatory intelligence;

Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;

Ability to establish and maintain effective working relationships with coworkers, managers and clients;

Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;

Ability to work on several projects, with direction from senior staff as appropriate;

Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;

Ability to make decisions on discrete tasks under senior supervision;

Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;

Experience of involvement in privacy regulatory strategy and determination of documentation requirements, timelines,;

Project leadership experience;

Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;

Problems faced are general and may require understanding of broader set of issues, but typically are not complex;

Ability to adapt quickly to a rapidly changing environment;

Required Licenses and Certifications

Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

Standard ADA Settings

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Office Environment

Physical Demands

Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.

Use hands and fingers to handle and manipulate objects and/or operate equipment.

Travel Requirements

Occasional

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.