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Form of workArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
Candidate must be team orientated 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
Qualifications and Experience:
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. Please take note this is a FULL time 40 hour work week. We are looking for someone with experience working as a MW for a major Pharma.
Prior experience in oncology is a plus.
The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team.
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3348 | Fax: 973.998.2599
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