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Director, Regulatory Liaison, Vaccine/Infectious Disease. Job in Rahway, New Jersey, United States in Merck & Co., Inc.. Nelest.com
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Director, Regulatory Liaison, Vaccine/Infectious Disease

col-narrow-left   

Job ID:

22148

Location:

Rahway, NJ 

Job function:

Legal Services
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Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Regulatory Liaison, Vaccine/Infectious Disease

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 Director, Liaison is responsible for developing product regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects within Therapeutic Area, functioning as the single, accountable, global point of contact on those projects. Functions as first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for Merck, where no regulatory guidance exists, where the program is extremely accelerated, is a Joint Venture endeavor, there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed Infectious Disease drugs/ Vaccines/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval of all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

Primary activities include, but are not limited to:
  • Reports to Executive Director, Therapeutic Area Lead, Antibacterials & Antifungals
  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
  • Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
  • As the strategic regulatory expert, advise CMC Regulatory Affairs on the regulatory impact of Chemistry, Manufacturing and Control changes on registration strategies and coordinate timing of CMC variations with clinical variations.
  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
  • Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail, chair meetings between company and FDA, prepare Merck teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
  • Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from Merck to external agencies and investigators.
  • Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
  • Represent GRACS within internal Merck committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC ), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), Label as Driver (LAD), and LEAD. Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.


Travel: Yes, 5 % of the Time Description Director, Regulatory Liaison, Vaccine/Infectious Disease-REG002183 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 Director, Liaison is responsible for developing product regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects within Therapeutic Area, functioning as the single, accountable, global point of contact on those projects. Functions as first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for Merck, where no regulatory guidance exists, where the program is extremely accelerated, is a Joint Venture endeavor, there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed Infectious Disease drugs/ Vaccines/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval of all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Primary activities include, but are not limited to:
  • Reports to Executive Director, Therapeutic Area Lead, Antibacterials & Antifungals
  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
  • Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
  • As the strategic regulatory expert, advise CMC Regulatory Affairs on the regulatory impact of Chemistry, Manufacturing and Control changes on registration strategies and coordinate timing of CMC variations with clinical variations.
  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
  • Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail, chair meetings between company and FDA, prepare Merck teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
  • Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from Merck to external agencies and investigators.
  • Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
  • Represent GRACS within internal Merck committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC ), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), Label as Driver (LAD), and LEAD. Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.

Job Requirements:

Qualifications Education:
  • M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline required. M.S. (see below).

Required:
  • M.D. with minimum of 5 years drug development or clinical experience
  • PhD or other related doctoral degree with minimum of 7 years relevant drug development experience required.
  • M.S. or comparable degree in health professions with minimum of 10 years relevant drug development experience, a majority of which was in Regulatory Affairs.




Preferred:
  • Anti-infectives, Antibacterial agents, Antifungal agents, Infectious Disease experiences/expertise and/or Vaccine expertise.
  • Substantial experience in regulatory affairs and administration.
  • Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.




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:

7065

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

Director, Regulatory Liaison, Vaccine/Infectious Disease

col-narrow-left   

Job ID:

22148

Location:

Rahway, NJ 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Regulatory Liaison, Vaccine/Infectious Disease

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 Director, Liaison is responsible for developing product regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects within Therapeutic Area, functioning as the single, accountable, global point of contact on those projects. Functions as first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for Merck, where no regulatory guidance exists, where the program is extremely accelerated, is a Joint Venture endeavor, there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed Infectious Disease drugs/ Vaccines/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval of all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

Primary activities include, but are not limited to:
  • Reports to Executive Director, Therapeutic Area Lead, Antibacterials & Antifungals
  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
  • Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
  • As the strategic regulatory expert, advise CMC Regulatory Affairs on the regulatory impact of Chemistry, Manufacturing and Control changes on registration strategies and coordinate timing of CMC variations with clinical variations.
  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
  • Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail, chair meetings between company and FDA, prepare Merck teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
  • Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from Merck to external agencies and investigators.
  • Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
  • Represent GRACS within internal Merck committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC ), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), Label as Driver (LAD), and LEAD. Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.


Travel: Yes, 5 % of the Time Description Director, Regulatory Liaison, Vaccine/Infectious Disease-REG002183 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 Director, Liaison is responsible for developing product regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects within Therapeutic Area, functioning as the single, accountable, global point of contact on those projects. Functions as first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for Merck, where no regulatory guidance exists, where the program is extremely accelerated, is a Joint Venture endeavor, there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed Infectious Disease drugs/ Vaccines/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval of all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Primary activities include, but are not limited to:
  • Reports to Executive Director, Therapeutic Area Lead, Antibacterials & Antifungals
  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
  • Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
  • As the strategic regulatory expert, advise CMC Regulatory Affairs on the regulatory impact of Chemistry, Manufacturing and Control changes on registration strategies and coordinate timing of CMC variations with clinical variations.
  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
  • Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail, chair meetings between company and FDA, prepare Merck teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
  • Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from Merck to external agencies and investigators.
  • Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
  • Represent GRACS within internal Merck committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC ), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), Label as Driver (LAD), and LEAD. Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.

Job Requirements:

Qualifications Education:
  • M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline required. M.S. (see below).

Required:
  • M.D. with minimum of 5 years drug development or clinical experience
  • PhD or other related doctoral degree with minimum of 7 years relevant drug development experience required.
  • M.S. or comparable degree in health professions with minimum of 10 years relevant drug development experience, a majority of which was in Regulatory Affairs.




Preferred:
  • Anti-infectives, Antibacterial agents, Antifungal agents, Infectious Disease experiences/expertise and/or Vaccine expertise.
  • Substantial experience in regulatory affairs and administration.
  • Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.




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:

7065
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