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Technical Writer/Editor 2

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  • ID: 490628
  • Posted: 8/24/2021
  • Location: Tarrytown, NY
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 3 - 6 Months

Description

Acara Solutions is looking for a Technical Writer/Editor for our Client located in Tarrytown, NY.
  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Manages the document review process ensuring conflicting and ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to reach consensus on timelines for deliverables
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Manages all aspects of outsourced or internal CSR production and ensures project delivery
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
Pay and Benefits:                                                                                                    
  • The salary for this position is $ 45.00 per hour (Max Pay rate).
 
Job Requirements

 
Required Skills / Qualifications:
  • Master"s Degree with scientific/medical publication record in peer-reviewed journals
  • Minimum of 4 years" experience as Technical Writer/Editor

Preferred Skills / Qualifications:
  • PhD with scientific/medical publication record in peer-reviewed journals
  • Experience or knowledge in areas of hematology, blood cancers (i.e. Multiple Myeloma), renal disease (nephrology)
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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