Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people
Abbott Molecular Our Des Plaines, IL location
has an opportunity for Section Head - Medical Writing,
The Section Head has division responsibility for the creation of technical/scientific documents such as submissions, package inserts, labels, clinical brochures, operation/training manuals, customer letters, and troubleshooting guides, for diagnostic assays and instruments (US and international). Includes management of review/approval and final assembly processes.
2. Division responsibility for the creation, assembly, and maintenance of other documentation related to product development, design reviews, and process/test method validation.
3. Provide core support within the Diagnostics Division providing medical writing services to the On Market & Development Organizations.
4. Conduct medical literature searches to support medical assessments, medical opinion documents, and product requirement documents.
5. Provide support for submission/document updates that are a result of new requirements or product changes.
6. Support Commercial Organization by providing requested medical writing services to meet external customer needs.
8. Ensure the preparation and compilation of all required materials into a single comprehensive package of the quality and integrity needed to meet compliance, regulatory, and customer requirements.
9. Ensure the timely completion of all deliverables to meet business needs.
10. Own and recommend division medical writing processes to ensure accuracy and consistency of documents produced.
11. Serve as an organization liaison within the division, i.e., work closely with Division. Facilitate issue resolution across these functional areas as it relates to document content.
12. Establish partnerships across divisions to support and align with corporate initiatives such as electronic submissions.WHAT YOU WILL DO
- Lead and direct the preparation of technical/scientific documents such as submissions, package inserts, labels, clinical brochures, operation/training manuals, customer letters, and troubleshooting guides, for diagnostic assays and instruments (US and international).
- Manage review/approval and final assembly processes. Lead and direct the creation, assembly, and maintenance of other documentation related to product development, design reviews, and process/test method validation.
- Ensure the preparation and compilation of all required materials into a comprehensive package of the quality and integrity needed to meet compliance, regulatory, and customer requirements.
- Develop submission/labeling and project strategies to meet desired project completion dates.
- Anticipate problems and obstacles.
- Build and manage budgeted human and financial resources for effective and efficient implementation of division/cross-division goals and priorities.
- Continuously evaluate project staffing needs and adjust priorities when necessary to manage resources efficiently.
- Lead departmental and global process improvement initiatives.
- Keep current on changing submission and other document requirements and ensure they are incorporated into area activities.
- Actively pursue knowledge of new developments in regulatory requirements
- Proactively seek and evaluate new systems for document creation and management.
- Align departmental activities with the other functional areas and division goals
This position is accountable for the following:
Drive activities related to submission/labeling and other document preparation. Eliminate obstacles and difficulties. Ensure compilation into a comprehensive package where information being presented is accurate, complete, and easy to navigate. Design and implement an organization which can respond to the needs of the division/corporation and provide a meaningful work experience for employees Monitor projects to assure that committed results are met. Facilitate, negotiate, or arbitrate conflicting priorities. Ensure labels, package inserts, manuals, and troubleshooting guides are aligned with submission and project timelines. 6.Ensure new compliance requirements are incorporated into area activities. Evaluate and address project staffing needs and adjust priorities. Confirm that quality standards for accuracy and completeness are met by staff. Ability to meet these standards ensures timelines are met for product submissions and other deliverables.EDUCATION AND EXPERIENCE, YOU'LL BRING:EXPERIENCE:
- Minimum of 10 years relevant professional experience, in a related area such as R&D, Technical Product Development, Technical Operations Product Support, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
- Minimum 3 years management experience.
Preferred: WHAT WE OFFER
- Minimum, Bachelor's degree in science or Medical Technology.
- Proven leadership, management, coaching, and mentoring skills. Demonstration of strategic planning, resource planning, and project management.
- Good organization, communication, interpersonal, and team skills. Knowledge of ADD products desirable. Excellent written and oral communication skills.
- Superior attention to detail.
- Computer fluency in word processing, flow diagrams, spreadsheets, and project management software.
- Good working knowledge of personal computer software programs in Windows environment.
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
Learn more about our benefits that add real value to your life to help you live fully:
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities