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Executive Director, Regulatory Affairs- Oncology. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Executive Director, Regulatory Affairs- Oncology

col-narrow-left   

Job ID:

22186

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:

Executive Director, Regulatory Affairs- Oncology

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 Executive Director, reporting to Vice President, Worldwide Regulatory Group, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in Oncology. The individual functions with a high degree of independence and provides oversight for assigned products, directly manages some liaisons. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.
  • Create and implement global regulatory strategy for oncology products to minimize time to approval.
  • Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison's respective products as needed
  • Review and provide final approval of WMA subsections
  • Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message, Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.
  • Provide review of labeling, Manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet
  • Oversee regulatory due diligence activities for licensing candidate review
  • Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
  • Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning, staffing and related people-management responsibilities for liaisons within areas of responsibility.
  • Represent Merck as needed at external initiatives notably with regulatory authorities
Travel: Yes, 20 % of the Time Description Executive Director, Regulatory Affairs- Oncology-REG002125 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 Executive Director, reporting to Vice President, Worldwide Regulatory Group, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in Oncology. The individual functions with a high degree of independence and provides oversight for assigned products, directly manages some liaisons. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.
  • Create and implement global regulatory strategy for oncology products to minimize time to approval.
  • Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison's respective products as needed
  • Review and provide final approval of WMA subsections
  • Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message, Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.
  • Provide review of labeling, Manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet
  • Oversee regulatory due diligence activities for licensing candidate review
  • Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
  • Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning, staffing and related people-management responsibilities for liaisons within areas of responsibility.
  • Represent Merck as needed at external initiatives notably with regulatory authorities

Job Requirements:

Qualifications Education Requirement:

M.S. or B.S. with 12-15 years relevant drug development experience a majority of which was in Regulatory

Required:
  • Regulatory experience required with therapeutic area experience in Oncology
  • Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.
  • Outstanding interpersonal, communication and negotiation skills are required.
  • Demonstrated leadership attributes, experienced at building and leading high performing teams, exemplifies corporate and ethical integrity, drives success consistent with company values and priorities.
Preferred:
  • Experience with international regulatory authorities outside of USA, EU, JPN.
  • Medical devices and in-vitro diagnostics.
  • M.D. or PhD with 7-12 years relevant drug development experience preferably with 5 years in Regulatory

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, Regulatory Affairs- Oncology

col-narrow-left   

Job ID:

22186

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:

Executive Director, Regulatory Affairs- Oncology

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 Executive Director, reporting to Vice President, Worldwide Regulatory Group, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in Oncology. The individual functions with a high degree of independence and provides oversight for assigned products, directly manages some liaisons. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.
  • Create and implement global regulatory strategy for oncology products to minimize time to approval.
  • Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison's respective products as needed
  • Review and provide final approval of WMA subsections
  • Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message, Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.
  • Provide review of labeling, Manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet
  • Oversee regulatory due diligence activities for licensing candidate review
  • Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
  • Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning, staffing and related people-management responsibilities for liaisons within areas of responsibility.
  • Represent Merck as needed at external initiatives notably with regulatory authorities
Travel: Yes, 20 % of the Time Description Executive Director, Regulatory Affairs- Oncology-REG002125 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 Executive Director, reporting to Vice President, Worldwide Regulatory Group, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in Oncology. The individual functions with a high degree of independence and provides oversight for assigned products, directly manages some liaisons. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.
  • Create and implement global regulatory strategy for oncology products to minimize time to approval.
  • Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison's respective products as needed
  • Review and provide final approval of WMA subsections
  • Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message, Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.
  • Provide review of labeling, Manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet
  • Oversee regulatory due diligence activities for licensing candidate review
  • Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
  • Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning, staffing and related people-management responsibilities for liaisons within areas of responsibility.
  • Represent Merck as needed at external initiatives notably with regulatory authorities

Job Requirements:

Qualifications Education Requirement:

M.S. or B.S. with 12-15 years relevant drug development experience a majority of which was in Regulatory

Required:
  • Regulatory experience required with therapeutic area experience in Oncology
  • Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.
  • Outstanding interpersonal, communication and negotiation skills are required.
  • Demonstrated leadership attributes, experienced at building and leading high performing teams, exemplifies corporate and ethical integrity, drives success consistent with company values and priorities.
Preferred:
  • Experience with international regulatory authorities outside of USA, EU, JPN.
  • Medical devices and in-vitro diagnostics.
  • M.D. or PhD with 7-12 years relevant drug development experience preferably with 5 years in Regulatory

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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