Clinical/Managed Care Writer
|Reference # :||18-07613||Title :||Clinical/Managed Care Writer|
|Location :||Lawrenceville, NJ|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||09/11/2018 / 03/10/2019|
Clinical/Managed Care Writer
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical/Managed Care Writer for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
• Writes, edits, and manages the production of:
o Protocols for Health Economics & Outcomes Research (HEOR)
o Clinical Protocols and Amendments
o Expanded-Access Protocols
o Protocol Shells for Investigator-Sponsored Research (ISR)
o Risk Evaluation and Mitigation Strategy (REMS) Materials.
• Extensive, proven experience and skill in writing high quality, evidence-based scientific documents.
• Ability to interpret clinical data (eg, data tables and figures; SAS output).
• Proven project management and leadership skills.
• Excellent scientific, analytical, and conceptual skills, with rigorous attention to detail.
• Excellent editorial skills, with ability to apply AMA editorial guidelines to all documents written.
• Advanced degree in a biomedical, scientific, or communications discipline.
• DIA, AMWA, and/or BELS certification(s) desirable.
• At least 5 years of medical writing experience in preparing scientific, regulatory, and/or registrational documents, for example: clinical protocols, clinical protocol amendments, clinical study reports, components of the Common Technical Document, investigator brochures, primary manuscripts, outcomes research protocols, components of AMCP Dossiers.
• Experienced in developing and managing detailed timelines, assigning and tracking deliverables, and proactively anticipating problems and proposing solutions.
• Skilled in using templates (model documents) to write scientific documents.
• Skilled in using a Documentum-based system.
• In-depth knowledge of at least one of these therapeutic areas: oncology, virology, immunoscience, cardiovascular.
• Expert in FDA, ICH, and GCP guidelines for clinical research and data reporting.
• Able to understand and follow Client SOPs and Work Instructions.
• Highly proficient in the use of Microsoft WORD and POWERPOINT.
If hired, you will enjoy the following Eclaro Benefits:
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary