- Accountable for meeting the main objectives of clinical writing projects within established timelines, budgets; with an appropriate quality level for driving writing projects to timely completion and resolving conflicts, removing barriers and generating innovative ways to ensure teams achieve project goals.
- Responsible for effective communication among team members and holding team members accountable to agreed-upon project dates.
- Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.) and manage the development of direct reports, including creating performance assessments, goals, and growth plans.
- Assist in selection and supervision of agencies, freelance consultants, or other vendors while also, continually train/be compliant with all current industry requirements and provide leadership in the overall regulatory document strategy, working in collaboration with the Regulatory team.
- Provide expertise in project management of multiple compounds and/or projects and interface with external groups (e. g, PK, Toxicology, e-Submissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions.
- Determine clinical writing resource needs by managing both internal and outsourced personnel and also external contracted medical writing resources ensuring department understands/complies with appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
- Supports scientific and marketing objectives in development; through coordination, preparation, and approval of scientific documents within the Global Project Team.
- Provides oversight and project management of clinical writing projects within budget and in accordance with clinical and regulatory timelines by working closely with Global Project Teams and functional areas to develop project objectives and strategies and corresponding timelines and milestones.
- Effectively utilize project management tools and techniques to drive multiple projects; responsible for overall project management for several projects simultaneously and build cross-functional relationships and lead team meetings to address specific projects.
- Execute effective delegation, oversight and mentoring of permanent Abbott medical writers and contract writers working on multiple project teams while working directly with Global Project Heads, Assistant Directors, and Clinical Project Managers to develop/implement timelines to meet desired project completion dates.
- Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
- 8 years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D.
- Minimum 3 years of project management experience, preferably with regulatory document project management and 3 or more years of writing/editing and reviewing experience, preferably in the healthcare industry.
- Minimum 5 years of supervisory experience in employee development with a proven track record of collaborative teamwork and leadership.
- Expert knowledge of international regulations, requirements and guidance associated with document preparation and submissions, and; a working knowledge of current electronic document management systems and information technology including CTD content templates.
- Proven track record of managing internal/external resources, successful completion of significant projects using project management tools and processes, and timely delivery of quality products.
- Experience in human and financial resource management with excellent business communication skills and, an aptitude for summarization and detail orientation.
- Requires problem solving abilities at both strategic and operation levels to recognize potential scheduling, resource conflicts for projects and to provide recommendations.
- Identify issues impacting team alignment and implements resolutions to resolve team discord.
- Identify and anticipate potential department problems impacting ability to meet business goals and make recommendations to achieve best possible timeline and resource utilization.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 15 % of the Time
Job Type: Experienced