Note:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager and supervisors may assign other duties as needed. Knowledge, Skills, and Abilities Basic knowledge of applicable laws and regulations. Ability to work with limited supervision and initiate contacts essential to submission preparation. Ability to manage multiple and possibly conflicting priorities. Ability to work as part of the regulatory team to meet group objectives. Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures. Ability to clearly communicate verbally and in writing. Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents. Ability to work with other computer systems for filing supplements and reports. Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Education Requirements Bachelor's degree in a relevant discipline, or equivalent work experience. Experience Requirements 0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience. Equivalency Depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirement.

Example:

if a job level requires a Bachelors degree plus 4 years experience, an equivalency could include 8 years, an Associates degree with 6 years experience, or Master's or a Master's degree with 2 years experience. Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location:

NORTH AMERICA

USA :

NC-Clayton:

USNC0002

- Clayton Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID:

544545

Type:

Regular Full-Time Job Category:

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