Careers

Position Summary:

The Consultant – Scientific Writer at Aclairo is part of the Scientific Services Group (SSG), whose role is to write nonclinical study summaries (toxicology, DMPK, pharmacology) for inclusion in regulatory documents (e.g., background packages, INDs, NDAs, CTDs, and BLAs) and to QC documents written by others, according to applicable guidelines and company policies. Duties will also include literature searching and participation in writing and QC’ing of literature summaries and white papers. For employees interested in consulting, duties may include participating in the development of toxicology study plans, preparing study outlines, placing and monitoring toxicology studies, and reviewing protocols and reports.

Primary Responsibilities:

• Work independently and with stakeholders (i.e., consultant/senior consultant and clients) to prepare and QC study summaries for nonclinical regulatory documents under strict timelines
• Review regulatory documents for accuracy, content, and strategy
• Make decisions, in collaboration with stakeholders, on the scientific and regulatory content and format of documents and decide on steps needed to complete high-quality documents according to timelines
• Work independently and with stakeholders in planning and implementing nonclinical studies at CROs
• Conduct literature searches in collaboration with stakeholders and participate in summarizing literature results and writing or QC’ing literature summaries
• Participate as a member of the SSG in developing standard/default approaches for writing and QC’ing regulatory documents and other written materials, literature searching, study monitoring activities, and other SSG processes as requested
• Contribute input and expert consultations in individual areas of expertise as required
• Consistently meet billable hour targets
• Model, promote, and demonstrate collegiality and adherence to Aclairo values
• Maintain current scientific knowledge by initiating the appropriate internal or external educational/learning pursuits
• Ensure personal development goals are in place and carried out in agreed timeframe

Travel Requirements:

• Quarterly travel for face-to-face internal meetings and as needed upon client request (e.g., study monitoring)

Office Requirements:
Home Office Setting requirements

• Ability to sit at a computer terminal for an extended period
• Ability to lift or move up to 30 pounds
• Ability to travel to meet requirements of the position

Position Requirements (Education, knowledge, and skills):

• Bachelor’s degree in a scientific discipline (advanced degree a plus)
• Substantial experience in scientific writing
  • Preferred experience: writing nonclinical regulatory submission documents, including ADME, pharmacology, and toxicology; acting as a nonclinical study director in ADME or toxicology; and/or experience as a project toxicologist or study monitor
• Excellent people skills, written and oral English communication skills, and organizational skills
• Proficient in Microsoft Office Suite
  • Preferred experience: Facility with Starting Point templates
• Good time management skills

To perform this job successfully, an individual must be able to perform each of the primary responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the primary responsibilities.