Business Title    Manager, Publishing, Editing & Report Quality (PERQ)
Requisition ID    16364BR
Job Category    Biotechnology/Pharmaceutical
Locations    USA - Princeton, NJ
Shift    1
Job Posting    The Manager of Publishing, Editing & Report Quality (PERQ) is expected to ensure quality control and efficiency in the production of clinical documents for electronic regulatory filing. The responsibility of this position includes liaising with document contributors and managing the retrieval and preparation of clinical documents and their relevant appendices to support the reporting of results from clinical trials managed by Covance. The Manager tracks the progress and coordinates the production process between the regional medical writing, editing, and publishing team to compile, review, and produce regulatory documents within project timelines, and client specifications. This position is accountable for developing document standards and training writers, editors, publishers, and representatives of other clinical departments to provide documents that meet technical and regulatory requirements for filing in the eCTD format. The Manager is expected to acquire a competency in the use of MS Projects, Documentum and associated electronic publishing tools.
Education/Qualifications    •    BA or BS in life sciences, English, or business with a minimum of 5 years of experience in project management, quality assurance, business improvement, regulatory affairs, clinical operations, medical writing, editing, or electronic publishing.
Experience    •    Highly skilled in project management, tracking/evaluating metrics, and process improvements
•    Managerial experience in coordinating the work of a multi-departmental team
•    Familiarity with regulatory requirements for clinical documentation, medical writing, and publishing
•    Expertise in Quality Assurance and Quality Control procedures
•    Experience in reviewing clinical documents
•    Good interpersonal skills beneficial for liaising with study sponsors, sites, and project team members
•    Good written and verbal communication skills
•    Ability to write fluent and grammatically correct English with an appreciation of the differences between UK English and American English
•    Good word-processing skills
•    Good organizational and time management skills
•    Pays attention to detail
•    Ability to work to tight timelines while maintaining accuracy
•    Ability to work to a variety of client-driven specifications
•    Good team player

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.