Director, Project Management (Animal Health)

Merck & Co., Inc. Madison , NJ 07940

Posted 2 weeks ago

Requisition ID: RES002253

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's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.

The Director Project Management will lead global multifunctional project teams to drive the development and registration of new animal pharmaceutical products for MERCK Animal Health (MAH) R&D. In this critical role, the Director is responsible for all aspects of pharmaceutical product development and will lead cross-funcional teams to achieve the project plan on schedule, on target and within budget.

The Global Drug Discovery & Pharmaceutical Development Department drives the progression of pharmaceutical drug candidates from discovery through development to commercialization. As a global project leader of this department, the Director will develop and exectute strategies for drug development programs and ensure the required data for regulatory approval and commercial value are generated. Hence, this is a high-visibility project leadership position with the potential for significant impact on the future success of MERCK Animal Health.

Responsibilities include:

  • Accountable for making project-related decisions or recommendations, guided by the R&D plan, that impact project approval timelines and thus the ability to achieve MAH financial objectives. This requires familiarity with regulatory requirements for veterinary products, especially in the US and EU, and skills necessary to negotiate with the US FDA and other worldwide regulatory authorities in order to achieve successful product registration and commercialization on a timely basis.

  • Lead projects for new chemical entities in a diverse portfolio of novel anti-infectives, parasiticides, or internal medicine candidates, e.g. dermatitis, diabetes, oncology, ophthalmology or reproduction.

  • Directs and manages all project team activities to resolve technical issues and to ensure all project goals and timelines are achieved. This is accomplished by interacting with key stakeholders across divisions and influencing others internally and externally to complete their assigned tasks on schedule.

  • Takes a leadership role and acts as a facilitator and mentor to empower others during execution of the R&D project plan, has overall accountability for assigned projects, and communicates progress to MAH stakeholders.

  • Modifies project plans to address any technical / regulatory concerns and accurately reports and keeps current the MAH Project Management database.

  • Prepares and reviews study protocols and final reports to ensure alignment with project objectives, consistency with applicable regulations, and alignment with MAH policies.

  • Collaborates with Manufacturing to resolve any rate-limiting issues to ensure product availability during product development and launch.

  • Collaborates with Marketing to establish accurate market assumptions and sales estimates for new proposed projects.

  • Collaborates with Technical Service to develop product introduction strategy and assists during launch and post launch product defense activities.

  • Manages each project's budget; establishes yearly project budget, tracks expenses, and updates the R&D external budget report.

  • Develops innovative technologies, processes, new products, and claims that address current and future customer problems or needs.

  • Develops new project proposals and presents recommendations to others in company. Prepares invention disclosures and assists during the creation and review of patent applications.

This position will be based in Madison, NJ and will report to the Associate Vice President and Global Head of Drug Discovery & Pharmaceutical Development.

Qualifications

Education Minimum Requirement:

Qualified candidates will have a DVM and/or a Ph.D. in life sciences.


Required Experience and

Skills:

Qualified candidates must have at least 8 years experience in project management in the area of pharmaceutical development. The position requires a high energy level, team building skills, strategic thinking, judgement, and an ability to anticipate and address potential technical/regulatory/compliance issues.

Strong oral and written communication skills with an ability to effectively communicate to various functional groups in the organization and external regulatory authorities are critical. Strong business acumen. The candidate should have a focus on scientific excellence and the needs of customers.


Preferred Experience and

Skills:

The ideal candidate will have a personal drive for results and an ability to motivate other team members to deliver on project objectives. The ideal candidate has an ability to work independently, is highly organized, and can effectively multitask and prioritize. Attention to detail and focus on continuous improvement are also important traits for this role.

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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

OFCCP EEO Supplement

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of it's manifestations.

Job: Resch Science Proj/Prog Mgmnt

Other Locations:

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Hazardous Materials:

Company Trade Name: Merck

Nearest Major Market: New Jersey



icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Animal Health Quality Assurance Technology Administrator

Merck & Co., Inc.

Posted 2 days ago

VIEW JOBS 3/21/2019 12:00:00 AM 2019-06-19T00:00 Requisition ID: QUA008612 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 Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Administration: * Application support and maintenance activities for the Reliance platform, including user access, system troubleshooting, end user process support and change control * Troubleshoot interface issues with Reliance and SAP, RegDat, Phoenix, Supplier Transparency, PMA, etc * Participate in ongoing technical training for the development of skills and increased responsibilities with emphasis on compliance and Reliance platform. Computer System Validation: * Take an active project role, working with business resources, to develop needed capabilities using Reliance or other software. * Develop validation documentation and drive validation activities to completion. This may include writing documentation, protocol development, test execution and event resolution, communication, SOPs and Training. * Execution support for changes to existing applications * Creation and delivery of Reliance system training. Quality Assurance Technology support * Provide guidance and oversight for global computerized systems in terms of governance, validation, quality Review or other activities. * Provide site and regional support for metrics through Reliance, Spotfire and other tools. Qualifications Education Minimum Requirement: * Bachelor's degree in an appropriate scientific, engineering, Quality or Compliance field of study is required, IT experience a plus. Required Experience and Skills: * Strong Quality Mindset and quality/compliance background * Well versed with applications used within Quality or Labs as well as knowledge about SDLC, report development, graphing, etc. * Sufficient manufacturing/laboratory background to understand business challenges, ability to communicate with and to deliver training to the user community * Ability to troubleshoot and resolve technical issues on computerized systems. * Ability to manage multiple priorities in a fast paced environment * Proven organizational and time management skills. * Project Management Skills Preferred Experience and Skills: * At least five (5) years of work experience in a pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field with computerized systems. Ability to work within a matrix organization to align on expectations and resolutions. 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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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 OFCCP EEO Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it's manifestations. Job: Quality Operations Other Locations: Employee Status: Regular Travel: Yes, 15 % of the Time Number of Openings: 2 Shift (if applicable): 1st Hazardous Materials: No Company Trade Name: Merck Nearest Major Market: New Jersey Merck & Co., Inc. Madison NJ

Director, Project Management (Animal Health)

Merck & Co., Inc.