Job Description

JOB DESCRIPTION

The Manager of Electronic Publishing supervises and coordinates the activities of the Medical Writing Electronic Publishing Group. The departmental responsibility includes the preparation of Electronic Publishing, or components of, an eIND, eNDA, eBLA, eCTD, and other worldwide regulatory submissions while providing document life cycle management. This person leads the development and implementation of project-specific processes for sponsors with unique technology requirements and may act as the PPD liaison for regulatory submission with the sponsor.

The Manager also serves a quality review role and as such is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, PLAs, INDs), clinical/statistical reports and study protocols.

Job Qualification

Education and Experience:

• BS/BA degree
• 4+ years of relevant experience using Adobe Acrobat, XHTML, XML, or other appropriate markup language where navigation was used or
• An advanced degree and 3+ years of relevant experience
• 5+ years producing or managing the production of regulatory publishing deliverables
• Experience working in a LAN/WAN computer environment
• 1 year supervisory/management experience

Knowledge, Skills and Abilities:

• Thorough knowledge of regulatory requirements and guidances for document management and electronic submissions
• Advanced knowledge of Microsoft (MS) Word and MS Excel
• Advanced knowledge of electronic templates (must be particularly skilled in formatting and troubleshooting templates)
• Able to use exceptional organizational and interpersonal skills to manage several complex projects in parallel and to manage rapidly changing priorities
• Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables
• Ability to independently learn new technologies
• Strong presentation and communication skills
• Ability to train and mentor others
• Must have excellent analytical ability and organizational skills
• Must possess excellent editorial/proofreading skills
• Able to provide solid leadership to a diverse staff
• Able to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables. Able to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.