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Executive Director, CSRM. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Executive Director, CSRM

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Job ID:

22166

Location:

Upper Gwynedd, PA 

Job function:

Medical Services, Public Relations
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Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Executive Director, CSRM

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. Under the general direction of the CSRM TA Leader and Vice President, Chief Safety Officer, the Clinical Safety and Risk Management Physician for Oncology will be responsible for the overall clinical risk management and safety surveillance of assigned investigational products with a primary focus on early development candidates. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across the Merck portfolio of products. The CSRM Physician will drive delivery of safety input to clinical development of Early Oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature and post-approval use. The incumbent is responsible for close collaboration with the Clinical Research VP for oncology early development to provide safety input into early development opportunities from both internal research and external partners.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents. The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products. He/She will collaborate with appropriate cross-functional Merck departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio, including safety strategies to support product development with external partnerships. He/She will be responsible for leading all interactions regarding product safety issues with MRL governance committees and regulatory agencies. This senior role works closely with the Clinical Risk Management Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping develop and align processes to support the departmental objectives.


Travel: Yes, 10 % of the Time Description Executive Director, CSRM-DRU000469 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. Under the general direction of the CSRM TA Leader and Vice President, Chief Safety Officer, the Clinical Safety and Risk Management Physician for Oncology will be responsible for the overall clinical risk management and safety surveillance of assigned investigational products with a primary focus on early development candidates. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across the Merck portfolio of products. The CSRM Physician will drive delivery of safety input to clinical development of Early Oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature and post-approval use. The incumbent is responsible for close collaboration with the Clinical Research VP for oncology early development to provide safety input into early development opportunities from both internal research and external partners.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents. The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products. He/She will collaborate with appropriate cross-functional Merck departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio, including safety strategies to support product development with external partnerships. He/She will be responsible for leading all interactions regarding product safety issues with MRL governance committees and regulatory agencies. This senior role works closely with the Clinical Risk Management Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping develop and align processes to support the departmental objectives.
Qualifications Education Requirement:
  • Required: Medical Doctor
  • Preferred: Board Certification

Job Requirements:

Qualifications Education Requirement:
  • Required: Medical Doctor
  • Preferred: Board Certification
Required:
  • Experience in drug development required.
  • Experience in clinical safety, pharmacovigilance and/or risk management is required.
  • Demonstrated organizational leadership skills are required, preferably in the employment areas noted above
  • Must have excellent communication, writing and analytic skills

Preferred:

  • Minimum 5 years of employment in clinical development, drug safety or regulatory preferred



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

Executive Director, CSRM

col-narrow-left   

Job ID:

22166

Location:

Upper Gwynedd, PA 

Job function:

Medical Services, Public Relations
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Executive Director, CSRM

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. Under the general direction of the CSRM TA Leader and Vice President, Chief Safety Officer, the Clinical Safety and Risk Management Physician for Oncology will be responsible for the overall clinical risk management and safety surveillance of assigned investigational products with a primary focus on early development candidates. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across the Merck portfolio of products. The CSRM Physician will drive delivery of safety input to clinical development of Early Oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature and post-approval use. The incumbent is responsible for close collaboration with the Clinical Research VP for oncology early development to provide safety input into early development opportunities from both internal research and external partners.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents. The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products. He/She will collaborate with appropriate cross-functional Merck departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio, including safety strategies to support product development with external partnerships. He/She will be responsible for leading all interactions regarding product safety issues with MRL governance committees and regulatory agencies. This senior role works closely with the Clinical Risk Management Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping develop and align processes to support the departmental objectives.


Travel: Yes, 10 % of the Time Description Executive Director, CSRM-DRU000469 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. Under the general direction of the CSRM TA Leader and Vice President, Chief Safety Officer, the Clinical Safety and Risk Management Physician for Oncology will be responsible for the overall clinical risk management and safety surveillance of assigned investigational products with a primary focus on early development candidates. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across the Merck portfolio of products. The CSRM Physician will drive delivery of safety input to clinical development of Early Oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature and post-approval use. The incumbent is responsible for close collaboration with the Clinical Research VP for oncology early development to provide safety input into early development opportunities from both internal research and external partners.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents. The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products. He/She will collaborate with appropriate cross-functional Merck departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio, including safety strategies to support product development with external partnerships. He/She will be responsible for leading all interactions regarding product safety issues with MRL governance committees and regulatory agencies. This senior role works closely with the Clinical Risk Management Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping develop and align processes to support the departmental objectives.
Qualifications Education Requirement:
  • Required: Medical Doctor
  • Preferred: Board Certification

Job Requirements:

Qualifications Education Requirement:
  • Required: Medical Doctor
  • Preferred: Board Certification
Required:
  • Experience in drug development required.
  • Experience in clinical safety, pharmacovigilance and/or risk management is required.
  • Demonstrated organizational leadership skills are required, preferably in the employment areas noted above
  • Must have excellent communication, writing and analytic skills

Preferred:

  • Minimum 5 years of employment in clinical development, drug safety or regulatory preferred



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
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