Report Writer I

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Job description

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Report Writer is responsible for writing/editing technical products including study protocols and study reports for the wide variety of assays that are offered as part of our Biologics Services organization. Report Writers require a broad understanding of writing/editing, as well as working knowledge of assays or tests required to characterize product or material safety. Report Writers understand scientific observations and ensure that reports meet the generally accepted professional/industry standards. You will maintain an understanding of technological principles and applications of the organization's services. You will work hand in hand with all other groups within the Toxicology organization to prepare technical reports that are received directly by our clients for their regulatory submissions.

• Review lab data/ workbooks and accurately represent the data in the final report
• Identify and/or resolve issues with study raw data/ information appropriately with relevant staff
• Monitor department's performance in the reporting process including tracking deadlines On Time Delivery (OTD) and Document Error Rate (DER) metrics
• Coordinate and plan work within technical team to meet and improve deadlines
• Obtain required signatures and transfer study reports to the appropriate personnel
• Communicate daily with other departments to resolve outstanding issues
• Assist in the preparation of SOPs and investigation reports relevant to area of report writing responsibility
• As appropriate generate, control and track revisions to study documentation including statements of work, protocols, protocol and report amendments, lab records, protocol and report templates
• Track status of laboratory testing and update Excel study tracking files, data trending as appropriate
• Other tasks and responsibilities as needed

Who You Are:

Minimum Qualifications:

• Bachelor's degree in a life sciences field (i.e. Microbiology, Biochemistry, etc.)
• 1+ years working experience in a pharmaceutical company and/or Contract Research Organization - OR - 1+ years hands-on laboratory experience - OR - 1+ years hands-on report writing experience

Preferred Qualifications:

• Knowledge of lab operations, global GLP regulations, and Toxicology testing guidelines
• Technical writing experience
• Excellent PC skills, including (but not limited to) Excel, Word and Adobe
• Utilizes problem solving skills and exercises good judgment

RSRMS

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits -

Curious? Apply and find more information at

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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