Sr. Associate, Information Management, Nonclinical Drug Safety

Job Description

Within the dynamic environment of Nonclinical Drug Safety (NDS), a Sr. Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for internal studies and those acquired from external efforts. 

Responsibilities:

• Constructing, supporting, and managing regulatory documents and components.

• Careful collaboration with internal and external stakeholders.

• Quality review to ensure that regulatory documents are appropriate, complete and consistent with regulatory expectations.

Minimum qualifications required:

• BS/BA degree in a relevant area with commensurate experience, or a non-BS/BA degree with significant experience in field.  Relevant degrees include biological, chemical, computer science, and medical science disciplines.

• 5-7 years of relevant experience

Required experience and skills:

• Experience with nonclinical drug development

• Significant experience with Microsoft Office Suite and related computer systems tools

• Significant attention to detail and quality attributes

• Solid command of English grammar, and robust editing & proofreading skills. 

• Strong candidates will demonstrate good leadership skills as well as the ability to work and communicate effectively

Preferred experience & education:

• Experience with publishing tools

• Have a solid understanding of applicable GxP regulations (highly preferred)

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

#EligibleforERP

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity