Sign In
 [New User? Sign Up]
Mobile Version

Global Regulatory Affairs and Clinical Safety Quality & Compliance Associate

Merck


Date:
07/20/2017
2017-07-202017-08-19
Job Code:
COM000527
Merck
  •  
  • Save Ad
  • Email Friend
  • Print

Job Details

Job Title: Global Regulatory Affairs and Clinical Safety Quality & Compliance Associate  - COM000527

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

 

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

 

Essential functions include but are not limited to: working independently, with guidance as needed, to plan and execute operational activities (i.e., deviation investigations, audit/inspection support, quality assessments, risk mitigation plans). Contributes to complex projects within Global Regulatory Affairs and Clinical Safety (GRACS) and across all divisions as needed to achieve overall quality goals. Assignments are of moderate complexity and require specific knowledge unique to the functional area; as well as, a broad understanding of GRACS and specific functional area processes and SOPs.

Primary activities include but are not limited to :

  • Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience with guidance and support from the GRACS leadership team and colleagues within and external to GRACS, as needed.
  • Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate. 
  • May manage the planning of functional group activities to achieve functional area and/or departmental objectives.
  • Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, and Good Clinical Practice), safety guidelines and company policies and procedures.
  • May assist with the preparation or review of relevant SOPs or policies relevant to GRACS or partnering organizations.
  • Collaborates effectively across areas within GRACS and partnering organizations to achieve quality goals.
  • May develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding across GRACS and partnering areas, where applicable.


Qualifications

Education:

  • BS/BA degree in relevant area with extensive experience in field.

Required: 

  • Collaboration and Partnering: Effectively partners with others to accomplish quality goals; possesses group leadership skills.
  • Communication Skills: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills. Comfortable facilitating global meetings.
  • Problem Solving: Demonstrates advanced level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
  • Strategic Thinking: Effectively applies skills to drive or participate in change efforts to enhance processes within GRACS or across areas within MRL that improve quality and /or add value to the business.
  • Project Management: Demonstrates advanced ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
  • Decision Making: Effectively applies skills to utilize knowledge, networks and data to support rapid decision making.

Preferred:

  •  Business Operations/Knowledge of Field: Effectively applies knowledge of regulations and business trends and applies this knowledge to optimize daily activities and collaborates with GRACS Quality and Compliance management to make appropriate decisions that improves the quality of business and functional area outputs.
  • Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure MRL QA and appropriate functional areas within GRACS are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at .

  

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.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Compliance And Ethics

Primary Location NA-United States

Other Locations NA-US-PA-Upper Gwynedd, NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 2

Featured Jobs[ View All ]