Coordinates the protocol, clinical study report and Investigator's Brochure writing efforts. Interacts with medical writing vendors and cross-functional teams and participates in project team meetings. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Develops and maintains clinical document project timelines. Liaises with cross functional teams and external vendors to ensure timely production of documents. Organizes, conducts, and leads document production meetings and other meetings as necessary.
Provides input on agendas and maintains meeting minutes. Ensures adherence to Medical Writing processes. Routes clinical documents for review and approval.
Assists with distribution and control of clinical and regulatory documents. Maintains all aspects of documentation. Coordinates QC review and archives QC documents.
Ensures consistency across clinical documents and adherence to regulatory publishing requirements. Helps to ensure compliance with regulatory and Good Clinical Practices (GCP) requirements. Participates in implementation of department infrastructure such as, document management system, and maintenance of templates and medical writing processes. Other duties as assigned.
A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired.
Equivalent experience may be accepted. A minimum of 2 years experience in the a pharmaceutical, biotech, medical products industry or CRO is required. Strong organizational and project management skills are required.
Must have demonstrated problem solving abilities. Strong written and verbal communication skills are required.
Must be willing to work as part of a team.
Must have demonstrated good interpersonal skills. Good computer skills are required. PMP certification is a plus. Working knowledge of MS word, Excel, Power point, and Outlook is a plus.