Covance Project Manager, Regulatory Affairs (GCP experience required) in Tokyo Ireland, Japan

Job Description:

NOTE: GCP and pharmaceutical industry experience REQUIRED.

Global Regulatory Affairs (GRA) is responsible for ensuring the quality of documents and submissions to regulatory authorities globally in support of both investigational and marketed product activities. GRA is also responsible for authoring medical & regulatory documents and providing strategic input for projects as required.

This position is responsible for the management of activities to ensure timely preparation/co-ordination of regulatory affairs activities for a particular project and must work to high standards (governmental, Sponsor, Covance and self) with minimal supervision. It is the responsibility of this position to ensure that all GRA deliverables for a project are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research. This position is accountable for communicating updates and issues to the team members as well as meeting the established timelines.

Responsibilities typically include developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.

Experience in US and EU regulatory processes.

This is a virtual position.

Requisition ID: 65304BR

Job Category: Regulatory Affairs

Locations: United States - Alice, TX, United States - Battle Creek, MI, United States - Emeryville, CA, United States - Chantilly, VA, United States - Cumberland, VA, United States - Denver, PA, Ireland - Dublin, France, United States - Gaithersburg, MD, Germany, United Kingdom - Leeds, United Kingdom - Harrogate, France - Paris, Germany - Munich, Germany - Muenster, NRW, Italy, Poland, Poland - Warsaw, United Kingdom - Crawley, United Kingdom - Horsham, United Kingdom - Maidenhead, United States - Evansville, IN, United States - Indianapolis, IN, United States - Kalamazoo, MI, United States - Madison, WI, United States - Nashville, TN, United States - Princeton, NJ, United States - Reno, NV, United States - San Diego, CA, Japan - Tokyo, Ireland, Italy - Rome, United States - Dedham, MA, United States - Austin, TX, United States - Dallas, TX, United States - Daytona Beach, FL, United States - Boise, ID, United States - Portland, OR, United States - Scottsdale, AZ, United States - Chandler, AZ, United States - Phoenix, AZ, United States - Conshohocken, PA, United States - Greenfield, IN, United States - Seattle, WA, France - Porcheville, United Kingdom - Alnwick, United States - Atlanta, GA, United States - Baltimore, MD, United States - Boston, MA, United States - Charlotte, NC, United States - Chicago, IL, United States - Cincinnati, OH, United States - Cleveland, OH, United States - Columbus, OH, United States - Detroit, MI, United States - Fort Lauderdale, FL, United States - Fort Myers, FL, United States - Hartford, CT, United States - Houston, TX, United States - Kansas City, MO, United States - Las Vegas, NV, United States - Memphis, TN, United States - Miami, FL, United States - Minneapolis, MN, United States - New Orleans, LA, United States - New York, NY, United States - Newark, NJ, United States - Oakland, CA, United States - Orlando, FL, United States - Philadelphia, PA, United States - Pittsburgh, PA, United States - Raleigh-Durham, NC, United States - Sacramento, CA, United States - Salt Lake City, UT, United States - San Antonio, TX, United States - San Francisco, CA, United States - San Jose, CA, United States - Santa Ana, CA, United States - Tampa, FL, United States - Washington, DC, United Kingdom - London, United States - Los Angeles, CA, United States - Denver, CO, United States - Burlington, NC, United States - Morrisville, NC, United States - West Trenton, NJ, United States - Cranford, NJ, United States - Brentwood, TN, United States - Research Triangle Park, NC, United States - Brea, CA

Shift: 1

Job Postings: NOTE: GCP and pharmaceutical industry experience REQUIRED.

Global Regulatory Affairs (GRA) is responsible for ensuring the quality of documents and submissions to regulatory authorities globally in support of both investigational and marketed product activities. GRA is also responsible for authoring medical & regulatory documents and providing strategic input for projects as required.

This position is responsible for the management of activities to ensure timely preparation/co-ordination of regulatory affairs activities for a particular project and must work to high standards (governmental, Sponsor, Covance and self) with minimal supervision. It is the responsibility of this position to ensure that all GRA deliverables for a project are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research. This position is accountable for communicating updates and issues to the team members as well as meeting the established timelines.

Responsibilities typically include developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.

Experience in US and EU regulatory processes.

This is a virtual position.

Education/Qualifications: • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

• Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulation.

• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Broad knowledge of drug development process and client needs.

• Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).

• Working knowledge of project management processes, especially as it relates to clinical development.

• Working knowledge of time and cost estimate development.

Preferred:

• PMP certification.

• Working knowledge of Covance and the overall structure of the organization.

• Basic knowledge of Covance sales and business development strategies and procedures.

• Working knowledge of Covance SOPs.

Experience: Minimum Required:

• At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development.

• Excellent communication skills, organization and planning skills and attention to detail.

• Demonstrated skills and competency in project management tasks and ability to work independently.

• Experience in managing projects in a virtual environment.

• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.

• Financial awareness and ability to actively utilize financial tracking systems.

• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

• Demonstrated ability to lead by example and to encourage team members to seek solutions independently.

• Ability to negotiate and liaise with clients in a professional manner.

• Ability to present to staff at all levels.

• Good computer skills with good working knowledge of a range of computer programs.

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.