-Business and operational management of local Document Consultancy site. Management of (project management and line
management) a group of approximately 15 medical writers and publishers, plus cross-functional matrix management.
-Manage quality, timeliness, efficiency and high scientific standards for written and electronically published documents
produced by the local coDOC group and for global teams, across geographical boundaries, producing documents for submission to
regulatory authorities.
-May act as Global Coordinator for Document Consultancy group.
- Participate in priority setting, workload distribution and resource planning to ensure adequate assignment of writing and
publishing resource to global projects..
- Act as submission coordinator, especially for heavy weight projects, to ensure effective use of global medical writing
and/or publishing resources for dossier preparation and ensure production of Common Technical Document
- As appropriate, act as program medical writer or program publisher for high priority programs in clinical development and,
as dictated by project needs and resource capacity, write, edit or publish clinical documents.
- Act as scientific, submission and medical writing consultant to provide authoritative technical and professional advice to
other line functions in Development.
Requirements:
- Expertise in medical writing.
- Expertise in data interpretation and presentation.
- Extensive experience of data interpretation and presentation for clinical development programs and scientific and medical
journal publications to support marketing activities.
- Submission experience is required.
- Expert knowledge of regulatory requirements across diverse geographical and regulatory boundaries.
- Excellent knowledge of regulatory and marketing document requirements, creation, management and publishing processes and
tools.
- Experience with matrix management and global environment.
- Ability to coach, mentor, lead cross-functional teams.
- Compensation: $75K-$85k
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.
PostingID: 708225958