CGI Technologies and Solutions, Inc. Program Manager - Regulatory Operations (RIM) in Plymouth Meeting, Pennsylvania

Program Manager - Regulatory Operations (RIM)

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Category:Project Management

City:Plymouth Meeting, Pennsylvania, United States

Position ID:J0818-0003

Employment Type:Full Time

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Position Description:

CGI is looking for a client-facing Regulatory Operations subject matter expert to help lead a team of regulatory consultants. The team is a onshore / offshore blend and are working on a project entailing regulatory data classification, remediation and enrichment of metadata to prepare countries for submissions archive content migrations to a global, cloud-based solution. This role will be responsible for engaging with both high-level business and IT leadership at the client organization to assure successful regulatory business outcomes and program delivery. The ideal candidate has a strong Regulatory Operations background in the key areas of authoring, submissions, labeling, and/or publishing and a focus on delivery with excellence while maintaining quality and compliance. They must also have demonstrated experience in consulting, whether internally or externally in the Life Sciences industry and preferably in Regulatory Operations.

In addition the successful candidate will assist the account team(s) at multiple client locations to help bolster the pursuit of Regulatory and related business.

FUTURE DUTIES AND RESPONSIBILITIES

The Regulatory SME will be a critical team member and will be responsible for providing oversight, guidance and hands on expertise to the team in specific capacities within the project.

As the Regulatory SME, the successful candidate will interface with the onshore and offshore team on a daily basis, providing guidance and assistance as needed. In addition the SME will participate directly with the client on global projhect calls helping the in scope countries prepare for their work (explain and share info), review along the way and help prepare the final deliverables.

Your future duties and responsibilities:

The Regulatory SME will be a critical team member and will be responsible for providing oversight, guidance and hands on expertise to the team in specific capacities within the project.

As the Regulatory SME, the successful candidate will interface with the onshore and offshore team on a daily basis, providing guidance and assistance as needed. In addition the SME will participate directly with the client on global project calls helping the in scope countries prepare for their work (explain and share info), review along the way and help prepare the final deliverables.

Required qualifications to be successful in this role:

At least 10-15 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology, Medical Devices or Pharmaceutical industries;

Proven leadership in key areas of Regulatory Operations

o Submissions - Both NeeS and eCTD knowledge and experience are required.

o Authoring – Collaborative Authoring Experience is a plus

o Labeling

o RIM and IDMP xEVMPD – Specifically cloud based experience with Regulatory Information Management Systems and Projects

Consulting Experience - 5+ years external or demonstrated equivalent internal consulting skills.

Proven leadership and program management experience;

Creative thinker, motivational leader, strong manager and team member

Strong o365 skills, project management skills, and a high attention to detail;

Strong communication skills (both written and oral); and is passionate about growing a strong and productive global regulatory operations practice within a global client

Skills:

  • Communication (Oral/Written)

What you can expect from us:

Build your career with us.

It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.

At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.

Be part of building one of the largest independent technology and business services firms in the world.

Learn more about CGI at www.cgi.com .

No unsolicited agency referrals please.

CGI is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .

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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.

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CGI is committed to the principles of equal employment opportunity and to compliance with US laws and regulations. Click here at http://documents.njoyn.com/homebase/cgi/AMSDocs/EEOPolicy-Signed2017.pdf to access our US EEO/Affirmative action policy.

Applicants have rights under Federal Employment Laws:

  1. EPPA at https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

  2. FMLA at https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

  3. Consolidated EEO Is The Law at http://documents.njoyn.com/homebase/cgi/AMSDocs/EEO_Poster.pdf

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

We make it easy to translate military experience and skills! Click here at http://cgi-veterans.jobs/ to be directed to our site that is dedicated to veterans and transitioning service members.