Assoc Prin Scientist, Regulatory Liaison Job

Assoc Prin Scientist, Regulatory Liaison-REG002552

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.


Description:

The Regulatory Affairs Headquarters R4, Senior Scientist supports products in the oncology therapeutic area as part of a regulatory team. He/She will have excellent communication and collaboration skills and will work closely with a global liaison to help develop and implement a global strategy for registration of oncology products and help manage regulatory submissions. His/her responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions. The Senior Scientist will report to a Global Regulatory Liaison (Director or Executive Director) and will work with one or more Regulatory Liaison Directors in the oncology therapeutic area).

Responsibilities:

- The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.

- Assisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications (sBLAs), requests for orphan drug and/or breakthrough designations and annual or other periodic reports. The individual will also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.

- Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications.

- Communicating with Agencies and attending Agency meetings as needed to assist the Global liaison.

- Participating as an active member on the global regulatory team. He/She will attend cross functional meetings as required, in collaboration with, and to assist the global liaison.

- Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global liaison in authoring of regulatory strategy documents.

- Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC) as well as other functional areas (e.g. clinical research, safety assessment).

- Support of Global liaison in label development.

- Assisting with process improvement initiatives.

- Performing regulatory administrative activities as needed in support of the oncology TA.

Qualifications

Education Requirements:

- Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

Requirements:

- Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 6 years of relevant experience in the pharmaceutical industry. Alternatively a Master’s or other advanced degree with at least 3 years of relevant experience in pharmaceutical industry.

- Must have excellent communication skills (both oral and written)Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

- Flexibility is required.

- Strong scientific and analytical skills with attention to detail.

Required Experience and Skills:

- Prior regulatory experience with any major regulatory agency is required.

Preferred Experience and Skills:

- Experience in clinical drug development.

- Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.

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.

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

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


Job: Regulatory Affairs Liaison

Job Title:Assoc Prin Scientist, Regulatory Liaison

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: None

Company Trade Name:Merck