US Tech Solutions is seeking a “Medical Writer" for a 12+ Months Contract position with a client in Woodcliff Lake, NJ.
- Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
- Responsibilities include preparation of regulatory documents on behalf of Client in accordance with the ICH guidelines, international regulations, Client standards and processes, and the Client Writing Style Guide as applicable.
- Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents.
- Participate in project team meetings to provide input regarding deliverables, timelines, and processes.
- Responsible for managing the document review process.
- Route documents for approval.
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
- The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
- Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred.
- Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite.
- Excellent regulatory writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.
- Experience: 5+ years’ writing experience in the pharmaceutical industry.
If you have the described qualifications and are interested in this exciting opportunity, apply today!
Benefits of Working with US Tech Solutions:
As a US Tech Solutions consultant, we are proud to offer access to the following benefits:
- Medical and dental insurance
- Bi-weekly payroll
- 401k plan
- Account and Delivery Manager for client support
- Referral program with the opportunity to earn additional income
About US Tech Solutions:
Your talent, our opportunities - This is the premise behind US Tech Solutions.
You have the skill we have the opportunity. As a team, we work passionately for you to get the right career opportunity across industry verticals and functions. For past sixteen years, leading Global
Companies and Fortune 500 come to us to get the right talent. Whether you want to work as full-time, contractor or part-time, technical or non-technical our talent consultants will connect with the right career opportunity globally.
Connect with our talent team today.
USTECH was founded in 2000 by Manoj Agarwal. Today, we are a global firm offering talent solutions to 150 customers including 20% of Fortune 500 across Financial Services, Healthcare, Life Sciences, Aerospace, Energy, Retail, Telecom, Technology, Manufacturing, and Engineering. We are headquartered in New Jersey with 40 global locations across the USA, Canada, Europe, and India. Deloitte has recognized USTECH as one of the fastest growing private businesses for the past five consecutive years and INC 500 for the past three. We have also been rated “The Top Business in the US" by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.
“US Tech is an Equal Opportunity Employer" and “US Citizens & all other parties authorized to work in the US are encouraged to apply."
Thank you for your time.
US Tech Solutions
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