Regulatory Affairs Specialist (Functional Service Partnership) - Contract Opportunity

Submission for the position: Regulatory Affairs Specialist (Functional Service Partnership) - Contract Opportunity - (Job Number: 169521)

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Various Seniority Levels

* Home-Based/Remote Based Contract Opportunity

*Full Time (FTE 1.0)

*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.

Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

Position Summary

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Various Seniority Levels

* Home-Based/Remote Based Contract Opportunity

*Full Time (FTE 1.0)

*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.

Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

Position Summary

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions

Supports the preparation of documentation and submissions under guidance. Coordinates and manages client deliverables supporting regulatory compliance. Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality and delivery. Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

Education and Experience Required Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills Good interpersonal skills to work effectively in a team environment Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Good negotiation skills Capable of working independently with direction and exercising independent judgment Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management Basic understanding of medical terminology, statistical concepts, and guidelines Good analytical, investigative and problem-solving skills Capable of interpreting data

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)

Essential Functions

Supports the preparation of documentation and submissions under guidance. Coordinates and manages client deliverables supporting regulatory compliance. Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality and delivery. Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

Education and Experience Required Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills Good interpersonal skills to work effectively in a team environment Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Good negotiation skills Capable of working independently with direction and exercising independent judgment Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management Basic understanding of medical terminology, statistical concepts, and guidelines Good analytical, investigative and problem-solving skills Capable of interpreting data

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)

US-CA-San Carlos, US-NJ-Pennington-FSP Hopewell NJ, US-AZ-Phoenix, US-WI-Middleton-FSP Middleton WI, US-MA-Waltham-FSP Waltham MA, US-NJ-Pennington, US-Florida, US-MA-Waltham, US-PA-Philadelphia-FSP Philadelphia PA, US-MD-Rockville-FSP Rockville MD, US-Minnesota-Minneapolis, US-KY-Highland Heights, US-CA-San Diego-FSP San Diego, CA, US-PA-Blue Bell-Blue Bell PA Harvest Dr, US-MA-Boston, US-Maryland, US-NY-New York, US-MA-Boston-FSP Boston MA, US-NC-Durham-FSP RTP NC Five Moore Drive, US-MA-Cambridge-FSP2 Cambridge, MA, US-KY-Highland Heights-Highland Heights KY Tesseneer, US-CA-South San Francisco, US-PA-Horsham-Horsham PA 2 Walnut Dr Ste 375, US-Kentucky, US-PA-Wayne, US-CA-San Carlos-FSP San Carlos CA, US-PA-Blue Bell, US-CA-South San Francisco-FSP San Francisco CA, US-NC-Durham, US-PA-King of Prussia-FSP King of Prussia PA, US-CA-Los Angeles, US-MD-Rockville-Rockville MD Research Blvd, US-NY-East Syracuse, US-Michigan, US-NJ-Hamilton, US-New York, US-District of Columbia-Washington, DC, US-FL-Miami, US-Minnesota, US-NJ-Cranbury, US-PA-King of Prussia, US-MD-Rockville, US-NC-Morrisville-Morrisville NC 3900 Paramount, US-WI-Middleton-Middleton WI Research Way, US-PA-Warminster, US-IL-Round Lake-FSP Roundlake IL, US-PA-Moon Township-FSP Moon Township PA FSP Dr, US-Texas, US-PA-Warminster-FSP Warminster PA, US-CA-Foster City, US-IL-Round Lake, US-Colorado, US-PA-Philadelphia-FSP2 Philadelphia, PA, US-PA-Moon Township, US-Georgia, US-Illinois, US-NJ-Summit, US-Colorado-Denver, US-Georgia-Atlanta, US-NY-East Syracuse-FSP Syracuse NY, US-PA-West Point-FSP West Point PA, US-NJ-Hamilton-Hamilton NJ Quakerbridge Rd, US-NJ-Summit-FSP Summit NJ, North America, US-VA-Richmond-Richmond VA Falmouth Street, US-IL-North Chicago, US-FL-Melbourne-Melbourne FL, US-NJ-Kenilworth, US-NJ-New Brunswick-FSP New Brunswick NJ, US-Ohio, US-PA-Philadelphia, US-Ohio-Cincinnati, US-Pennsylvania, US-NJ-New Brunswick, US-TX-Austin, US-NJ-Rahway-FSP Rahway NJ, US-NC-Wilmington, US-CA-Foster City-FSP Foster City CA, US-TX-Dallas, US-TX-Austin-Austin TX Metro Center Dr 300, US-NJ-Rahway, US-PA-Collegeville-FSP Collegeville PA, US-AZ-Tempe-Tempe AZ E Broadway Road, US-FL-Orlando-Orlando FL, US-PA-Horsham-Horsham PA 132 Welsh Rd #100, US-Massachusetts, US-MA-Devens, US-North Carolina, US-AZ-Tempe, US-MA-Cambridge, US-California, US-MD-Bethesda, US-FL-Orlando-Orlando Compass Clinic, US-WI-Middleton, US-PA-Philadelphia-FSP Phila PA Crescent Drive, US-FL-Melbourne, US-PA-Horsham, US-IL-Chicago, US-PA-Collegeville, US-IL-North Chicago-FSP North Chicago, US-Arizona, US-NJ-Kenilworth-FSP Kenilworth NJ, US-CA-San Francisco-FSP2 San Francisco CA, US-Nevada, United States, US-NJ-Basking Ridge-FSP Basking Ridge NJ, US-FL-The Villages, US-Michigan-Detroit, US-CA-San Diego-San Diego CA Scranton Road, US-FL-The Villages-The Villages, US-TX-Houston, US-New Jersey, US-NC-Morrisville, US-MA-Devens-FSP Devens MA, US-NJ-Princeton-FSP Lawrenceville NJ, US-CA-San Francisco, US-NJ-Basking Ridge, US-MA-Cambridge-FSP Cambridge MA, US-MD-Bethesda-Bethesda MD, US-FL-Orlando, US-District of Columbia, US-CA-San Diego, US-NJ-Princeton, US-FL-Ocala, US-WA-Seattle-FSP2 Seattle, US-TX-Austin-Austin TX Metro Center Dr 200, US-WA-Bothell, US-FL-Ocala-Neurohealth, US-NV-Las Vegas, US-WA-Seattle-FSP Seattle WA, US-VA-Richmond, US-NJ-Princeton-Princeton, US-NV-Las Vegas-Las Vegas NVUS-CA-San Carlos, US-NJ-Pennington-FSP Hopewell NJ, US-AZ-Phoenix, US-WI-Middleton-FSP Middleton WI, US-MA-Waltham-FSP Waltham MA, US-NJ-Pennington, US-Florida, US-MA-Waltham, US-PA-Philadelphia-FSP Philadelphia PA, US-MD-Rockville-FSP Rockville MD, US-Minnesota-Minneapolis, US-KY-Highland Heights, US-CA-San Diego-FSP San Diego, CA, US-PA-Blue Bell-Blue Bell PA Harvest Dr, US-MA-Boston, US-Maryland, US-NY-New York, US-MA-Boston-FSP Boston MA, US-NC-Durham-FSP RTP NC Five Moore Drive, US-MA-Cambridge-FSP2 Cambridge, MA, US-KY-Highland Heights-Highland Heights KY Tesseneer, US-CA-South San Francisco, US-PA-Horsham-Horsham PA 2 Walnut Dr Ste 375, US-Kentucky, US-PA-Wayne, US-CA-San Carlos-FSP San Carlos CA, US-PA-Blue Bell, US-CA-South San Francisco-FSP San Francisco CA, US-NC-Durham, US-PA-King of Prussia-FSP King of Prussia PA, US-CA-Los Angeles, US-MD-Rockville-Rockville MD Research Blvd, US-NY-East Syracuse, US-Michigan, US-NJ-Hamilton, US-New York, US-District of Columbia-Washington, DC, US-FL-Miami, US-Minnesota, US-NJ-Cranbury, US-PA-King of Prussia, US-MD-Rockville, US-NC-Morrisville-Morrisville NC 3900 Paramount, US-WI-Middleton-Middleton WI Research Way, US-PA-Warminster, US-IL-Round Lake-FSP Roundlake IL, US-PA-Moon Township-FSP Moon Township PA FSP Dr, US-Texas, US-PA-Warminster-FSP Warminster PA, US-CA-Foster City, US-IL-Round Lake, US-Colorado, US-PA-Philadelphia-FSP2 Philadelphia, PA, US-PA-Moon Township, US-Georgia, US-Illinois, US-NJ-Summit, US-Colorado-Denver, US-Georgia-Atlanta, US-NY-East Syracuse-FSP Syracuse NY, US-PA-West Point-FSP West Point PA, US-NJ-Hamilton-Hamilton NJ Quakerbridge Rd, US-NJ-Summit-FSP Summit NJ, North America, US-VA-Richmond-Richmond VA Falmouth Street, US-IL-North Chicago, US-FL-Melbourne-Melbourne FL, US-NJ-Kenilworth, US-NJ-New Brunswick-FSP New Brunswick NJ, US-Ohio, US-PA-Philadelphia, US-Ohio-Cincinnati, US-Pennsylvania, US-NJ-New Brunswick, US-TX-Austin, US-NJ-Rahway-FSP Rahway NJ, US-NC-Wilmington, US-CA-Foster City-FSP Foster City CA, US-TX-Dallas, US-TX-Austin-Austin TX Metro Center Dr 300, US-NJ-Rahway, US-PA-Collegeville-FSP Collegeville PA, US-AZ-Tempe-Tempe AZ E Broadway Road, US-FL-Orlando-Orlando FL, US-PA-Horsham-Horsham PA 132 Welsh Rd #100, US-Massachusetts, US-MA-Devens, US-North Carolina, US-AZ-Tempe, US-MA-Cambridge, US-California, US-MD-Bethesda, US-FL-Orlando-Orlando Compass Clinic, US-WI-Middleton, US-PA-Philadelphia-FSP Phila PA Crescent Drive, US-FL-Melbourne, US-PA-Horsham, US-IL-Chicago, US-PA-Collegeville, US-IL-North Chicago-FSP North Chicago, US-Arizona, US-NJ-Kenilworth-FSP Kenilworth NJ, US-CA-San Francisco-FSP2 San Francisco CA, US-Nevada, United States, US-NJ-Basking Ridge-FSP Basking Ridge NJ, US-FL-The Villages, US-Michigan-Detroit, US-CA-San Diego-San Diego CA Scranton Road, US-FL-The Villages-The Villages, US-TX-Houston, US-New Jersey, US-NC-Morrisville, US-MA-Devens-FSP Devens MA, US-NJ-Princeton-FSP Lawrenceville NJ, US-CA-San Francisco, US-NJ-Basking Ridge, US-MA-Cambridge-FSP Cambridge MA, US-MD-Bethesda-Bethesda MD, US-FL-Orlando, US-District of Columbia, US-CA-San Diego, US-NJ-Princeton, US-FL-Ocala, US-WA-Seattle-FSP2 Seattle, US-TX-Austin-Austin TX Metro Center Dr 200, US-WA-Bothell, US-FL-Ocala-Neurohealth, US-NV-Las Vegas, US-WA-Seattle-FSP Seattle WA, US-VA-Richmond, US-NJ-Princeton-Princeton, US-NV-Las Vegas-Las Vegas NVSubmission for the position: Regulatory Affairs Specialist (Functional Service Partnership) - Contract Opportunity - (Job Number: 169521)