Query SELECT `session_id` FROM `user_session_data_storage` WHERE `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Query INSERT INTO `user_session_data_storage` SET `last_activity` = NOW(), `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Senior Regulatory Operations Specialist - Financial Disclosure. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
Home  |  Contact  |  About Us
|   Register  |  Sign In

Senior Regulatory Operations Specialist - Financial Disclosure

col-narrow-left   

Job ID:

22185

Location:

Upper Gwynedd, PA 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Regulatory Operations Specialist - Financial Disclosure

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Financial Disclosure Specialist :Reports to the Financial Disclosure Associate Director -Regulatory Affairs -Global Regulatory Affairs Clinical Safety (GRACS) Merck Research Laboratories (MRL)Successful Candidate will: Coordinate specified activities surrounding compliance to the US Food and Drug Administration (FDA) regulation for "Financial Disclosure by Clinical Investigators" for all marketing applications filed with the FDA as required by that rule, as detailed below.

Primary Activities:
  • Perform data entry of information obtained from clinical investigators' financial disclosure forms into Merck's financial Disclosure database
  • Interact with all MRL Project Teams (Clinical and Regulatory) to determine the applicability of MRL clinical trials to regulatory requirements, meets with Clinical and Regulatory, as necessary, to ensure appropriate classification of trials and oversees the receipt of confidential financial information from investigators.
  • Participates in the training and education of Merck staff as well as clinical investigators regarding the requirements of this regulation.
  • As required, interacts with Global Human Health to provide required financial information for marketing trials that will be submitted to the FDA as new or supplemental applications.
  • Coordinates, through Clinical Research, efforts to ensure required update of financial information, as required by the regulation, from clinical investigators and, through the appropriate financial administrators, Merck financial databases worldwide.
  • Responsible for ensuring the timely and secure archival of financial information required to support summary information provided to the FDA.
  • Provides key information to MRL Finance, Legal and other corporate financial system administrators to allow for the complete and timely tracking of required information through internal systems.
  • Responsible for tabulating information and, where disclosure thresholds have been exceeded, notify management to allow for providing accurate explanations to support the control of bias in covered clinical trials, ensuring the accuracy of financial disclosure statements to Merck Corporate Finance.
  • Author the Financial Disclosure component when required by regulation (21CFR Part 54) to support submissions sent to the FDA
Travel: No Description Senior Regulatory Operations Specialist - Financial Disclosure-REG002220 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Financial Disclosure Specialist :Reports to the Financial Disclosure Associate Director -Regulatory Affairs -Global Regulatory Affairs Clinical Safety (GRACS) Merck Research Laboratories (MRL)Successful Candidate will: Coordinate specified activities surrounding compliance to the US Food and Drug Administration (FDA) regulation for "Financial Disclosure by Clinical Investigators" for all marketing applications filed with the FDA as required by that rule, as detailed below.
Primary Activities:
  • Perform data entry of information obtained from clinical investigators' financial disclosure forms into Merck's financial Disclosure database
  • Interact with all MRL Project Teams (Clinical and Regulatory) to determine the applicability of MRL clinical trials to regulatory requirements, meets with Clinical and Regulatory, as necessary, to ensure appropriate classification of trials and oversees the receipt of confidential financial information from investigators.
  • Participates in the training and education of Merck staff as well as clinical investigators regarding the requirements of this regulation.
  • As required, interacts with Global Human Health to provide required financial information for marketing trials that will be submitted to the FDA as new or supplemental applications.
  • Coordinates, through Clinical Research, efforts to ensure required update of financial information, as required by the regulation, from clinical investigators and, through the appropriate financial administrators, Merck financial databases worldwide.
  • Responsible for ensuring the timely and secure archival of financial information required to support summary information provided to the FDA.
  • Provides key information to MRL Finance, Legal and other corporate financial system administrators to allow for the complete and timely tracking of required information through internal systems.
  • Responsible for tabulating information and, where disclosure thresholds have been exceeded, notify management to allow for providing accurate explanations to support the control of bias in covered clinical trials, ensuring the accuracy of financial disclosure statements to Merck Corporate Finance.
  • Author the Financial Disclosure component when required by regulation (21CFR Part 54) to support submissions sent to the FDA

Job Requirements:

Qualifications Education:
  • BA/BS preferably in a science, health-related field or business

Required:
  • Minimum of two years of experience in Clinical or Regulatory Area, working knowledge/understanding of FDA regulations, excellent computer skills, good written and oral communication.
  • Broad range of knowledge of the regulatory processes, systems, and business requirements.
  • Ability to lead and influence others
  • Excellent interpersonal skills

Please Note: Financial background is not required. Although the title notes Financial Disclosure Specialist, a well rounded pharmaceuitical background is more advantageous.

Preferred:
  • Same as above
  • Process Management Knowledge
  • Advanced technical knowledge of computer systems









Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

19446

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Senior Regulatory Operations Specialist - Financial Disclosure

col-narrow-left   

Job ID:

22185

Location:

Upper Gwynedd, PA 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Regulatory Operations Specialist - Financial Disclosure

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Financial Disclosure Specialist :Reports to the Financial Disclosure Associate Director -Regulatory Affairs -Global Regulatory Affairs Clinical Safety (GRACS) Merck Research Laboratories (MRL)Successful Candidate will: Coordinate specified activities surrounding compliance to the US Food and Drug Administration (FDA) regulation for "Financial Disclosure by Clinical Investigators" for all marketing applications filed with the FDA as required by that rule, as detailed below.

Primary Activities:
  • Perform data entry of information obtained from clinical investigators' financial disclosure forms into Merck's financial Disclosure database
  • Interact with all MRL Project Teams (Clinical and Regulatory) to determine the applicability of MRL clinical trials to regulatory requirements, meets with Clinical and Regulatory, as necessary, to ensure appropriate classification of trials and oversees the receipt of confidential financial information from investigators.
  • Participates in the training and education of Merck staff as well as clinical investigators regarding the requirements of this regulation.
  • As required, interacts with Global Human Health to provide required financial information for marketing trials that will be submitted to the FDA as new or supplemental applications.
  • Coordinates, through Clinical Research, efforts to ensure required update of financial information, as required by the regulation, from clinical investigators and, through the appropriate financial administrators, Merck financial databases worldwide.
  • Responsible for ensuring the timely and secure archival of financial information required to support summary information provided to the FDA.
  • Provides key information to MRL Finance, Legal and other corporate financial system administrators to allow for the complete and timely tracking of required information through internal systems.
  • Responsible for tabulating information and, where disclosure thresholds have been exceeded, notify management to allow for providing accurate explanations to support the control of bias in covered clinical trials, ensuring the accuracy of financial disclosure statements to Merck Corporate Finance.
  • Author the Financial Disclosure component when required by regulation (21CFR Part 54) to support submissions sent to the FDA
Travel: No Description Senior Regulatory Operations Specialist - Financial Disclosure-REG002220 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Financial Disclosure Specialist :Reports to the Financial Disclosure Associate Director -Regulatory Affairs -Global Regulatory Affairs Clinical Safety (GRACS) Merck Research Laboratories (MRL)Successful Candidate will: Coordinate specified activities surrounding compliance to the US Food and Drug Administration (FDA) regulation for "Financial Disclosure by Clinical Investigators" for all marketing applications filed with the FDA as required by that rule, as detailed below.
Primary Activities:
  • Perform data entry of information obtained from clinical investigators' financial disclosure forms into Merck's financial Disclosure database
  • Interact with all MRL Project Teams (Clinical and Regulatory) to determine the applicability of MRL clinical trials to regulatory requirements, meets with Clinical and Regulatory, as necessary, to ensure appropriate classification of trials and oversees the receipt of confidential financial information from investigators.
  • Participates in the training and education of Merck staff as well as clinical investigators regarding the requirements of this regulation.
  • As required, interacts with Global Human Health to provide required financial information for marketing trials that will be submitted to the FDA as new or supplemental applications.
  • Coordinates, through Clinical Research, efforts to ensure required update of financial information, as required by the regulation, from clinical investigators and, through the appropriate financial administrators, Merck financial databases worldwide.
  • Responsible for ensuring the timely and secure archival of financial information required to support summary information provided to the FDA.
  • Provides key information to MRL Finance, Legal and other corporate financial system administrators to allow for the complete and timely tracking of required information through internal systems.
  • Responsible for tabulating information and, where disclosure thresholds have been exceeded, notify management to allow for providing accurate explanations to support the control of bias in covered clinical trials, ensuring the accuracy of financial disclosure statements to Merck Corporate Finance.
  • Author the Financial Disclosure component when required by regulation (21CFR Part 54) to support submissions sent to the FDA

Job Requirements:

Qualifications Education:
  • BA/BS preferably in a science, health-related field or business

Required:
  • Minimum of two years of experience in Clinical or Regulatory Area, working knowledge/understanding of FDA regulations, excellent computer skills, good written and oral communication.
  • Broad range of knowledge of the regulatory processes, systems, and business requirements.
  • Ability to lead and influence others
  • Excellent interpersonal skills

Please Note: Financial background is not required. Although the title notes Financial Disclosure Specialist, a well rounded pharmaceuitical background is more advantageous.

Preferred:
  • Same as above
  • Process Management Knowledge
  • Advanced technical knowledge of computer systems









Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

19446
Copyright © 2016 NELEST.COM All rights reserved