Key Accountabilities:

Quality Control (QC)

• Ensure that all work is complete and of high-quality.

• Edit clinical documents by checking language, grammar, technical terminology, accuracy of data and scientific content.

• Confirm consistency and integrity across the document.

• Perform format changes to documents based on guidelines.

• Ensure that the document adheres to specified style guides or client conventions.

• Independently perform quality review of clinical components of assigned documents (e.g. patient narratives, informed consent forms, disclosure documents, protocols, clinical study reports, investigator brochures, summary documents, regulatory responses, etc.). Formally document quality review findings for assigned documents using department specific procedures. Identify and immediately escalate any significant findings.

• Participate in resolution of findings with the document authors, and other team members, if necessary

• Analyze DQR findings to identify root causes of errors and discrepancies and participate in corrective action planning

Training Compliance

• Attend and complete mandatory, corporate, project-specific, and departmental training as required.

• Keep abreast of professional information and technology through workshops and conferences (when approved) and assure appropriate transfer of that information to the department.

• Provide guidance to new staff as well as less experienced staff.

General

• Attend departmental and company meetings as necessary.

• Comply with departmental procedures, such as completion of workload trackers.

• May participate in departmental or interdepartmental process improvement and training initiatives.

• Evaluate routine processes and procedures to identify areas that can be eliminated or streamlined. Make recommendations on process improvements that could reduce recurring errors in documents.

• Contribute to team initiatives like knowledge sharing exercises.

Skills:

• Impeccable written and verbal communication skills and strong command of the English language.

• Ability to deliver consistently high-quality output.

• Well-established proof-reading skills and ability to pay rigorous attention to detail.

• Demonstrate excellent interpersonal skills and proactivity.

• Take initiative and work in a solutions-driven manner.

• High level of numeracy, ability to interpret statistical data and an understanding of clinical research concepts would be an advantage.

• Client-focused approach to work.

• A flexible attitude with respect to work assignments and new learning.

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

• Willingness to work in a matrix environment and to value the importance of teamwork.

Knowledge and Experience:

• Experience in the pharmaceutical or clinical research organization industry and medical writing.

• Knowledge of regulatory documents and ICH-GCP guidelines, understanding of clinical research, and the drug development process.

• Proof reading, quality control and copyediting experience.

• Advanced word processing skills, including MS Office; software and systems knowledge or ability to learn and adapt to various IT systems; document management systems, collaborative authoring and file conversion and databases.

Education:

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent

• 4+ years of relavent experience.