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1+ months

Regulatory Technical Writer - 20 hrs/wk - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851
  • Jobs Rated
    40th
Regulatory Technical Writer Part-Time (20 hrs/week) ** NIH ** Rockville, MD



Kelly Government is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Regulatory Technical Writer (Part-Time ~ 20 hours/week) to work with the National Institutes of Health in Rockville, MD.



This is a part-time (20 hours/week), long-term contract position which offers:

- Competitive salary with leave, holiday pay, and retirement plan benefits

- Opportunity to work at NIH, world's foremost medical research center

- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com at http://www.kellygovernmentsolutions.com/



**TASKS/SERVICES** : The contractor shall:

(1) Perform detailed QC/QA audits (GLP and non-GLP) of non-clinical draft and final reports.

(2) Verify that data required by the protocol and protocol amendments is included in the report.

(3) Verify data in appendices against data in summary tables and text.

(4) Ensure that statements in text are supported by the data.

(5) Identify any missing data.

(6) Ensure that recommended/agreed upon changes identified in the draft report have been made in the subsequent draft and final report.

(7) Perform detailed QC/QA reviews of non-clinical draft protocols.

(8) Endure that all necessary information is included in the protocol.

(9) Identify unclear procedures.

(10) Assist in the preparation (writing, compiling or editing) of summary documents (i.e., tabular summaries, written summaries) for regulatory submission.

(11) Participate in on-site study report audits.

(12) Verify source data against reported data.

(13) Verify that procedures in SOPs and the study protocol were followed.

(14) Prepare list of discrepancies for inclusion in audit report.

(15) Generate protocols, as well as report shells, draft reports and related documents using source statistical reports or data.

(16) Oversee review cycles and incorporate reviewers comments.

(17) Ensure that publishing/formatting requirements are met.

(18) Review and edit clinical trial protocols or reports.

(19) Participate in Office of Regulatory Affairs (ORA) standing meetings, training and educational programs and efforts.

(20) Participate in the process of writing and reviewing policies and guidelines that harmonize ORA procedures and processes.



**REQUIREMENTS** : The contractor ideally would have:

(1) Masters degree in Biological Sciences or Life Sciences. Three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.

(2) Minimum three (3) years of experience in a related field.

(3) Demonstrates experience working in a clinical environment.

(4) Demonstrates experience with program and protocol management and budget tracking\

(5) Experience in the planning (site assessments, design, logistics), implementation, conduct, close-out and oversight of clinical trials.

(6) Experience in drafting, reviewing and finalizing documents for submission to FDA as part of IND, NDA, and BLA filings.

(7) Thorough understanding of FDA requirements for GLP-compliant final reports.

(8) Experience in reviewing and auditing nonclinical study protocols, reports and data both GLP and non GLP for submission to regulatory agencies.

(9) Experience in summarizing and collating large amounts of nonclinical pharmacology, toxicology and pharmacokinetic (Absorption, Distribution, Metabolism and Excretion) data for submission to regulatory agencies.

(10) Experience in eCTD/CTD document preparation for submission to regulatory agencies (both content and format).

(11) Experience in writing and reviewing clinical protocols and reports.

(12) Ability to communicate well and work in a team.

(13) Experience in working with a variety of CROs and pharmaceutical companies, as well as diverse organizational structures.

(14) Able to travel to attend site audits.



**PLEASE APPLY ONLINE**

Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Jobs Rated Reports for Technical Writer

Posted: 2019-12-20 Expires: 2020-02-08

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Regulatory Technical Writer - 20 hrs/wk - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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Technical Writer
40th2018 - Technical Writer
Overall Rating: 40/220
Median Salary: $70,930

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Growth
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