Offers “Abbott”

14 days agoAbbott

Section Head Medical Writing

  • Des Plaines, USA
  • Design / Civil engineering / Industrial engineering

Job description

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

· 
Career development with an international company where you can grow the career you dream of .

· 
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

· 
An excellent retirement savings plan with high employer contribution

· 
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

· 
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

· 
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Des Plaines, IL location in Abbott Molecular. This team has an opportunity for "Section Head - Medical Writing". This is a Sr. Manager level role with 6 reports.

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).

What You’ll Work On

1.  Management of review/approval and final assembly processes for submission documents.

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 Molecular 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 the 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.

In addition, you will also support the group with the following responsibilities:

· 
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.

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Continuously evaluate project staffing needs and adjust priorities when necessary to manage resources efficiently.

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Lead departmental and global process improvement initiatives.

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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.

Required Qualifications

· 
Minimum of 8 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.

· 
Minimum, Bachelor’s degree in science or Medical Technology.

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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.

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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.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is
$109,300.00 – $218,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AMD Molecular

        

LOCATION:

United States > Des Plaines : DP01

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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