Associate Director, Medical Writing and Ad Promo

About this role

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 your 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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity The Associate Director, Medical Writing and Ad Promo works out of our Itasca, IL location in the Abbott Molecular Division on site daily. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.  

What You’ll Work On The Associate Director Medical Writing and Ad Promo has division responsibility for the creation of technical/scientific documents such as submissions, package inserts, labels, clinical brochures, operation/training manuals, and review of advertisement and promotional materials for diagnostic assays and instruments (US, EU and international).

In addition: • Division responsibility for the creation of technical/scientific documents such as submissions, package inserts, labels, clinical brochures, operation/training manuals and troubleshooting guides, for diagnostic assays and instruments (US and international). Includes management of review/approval and final assembly processes.

• Provide core support within the Division providing medical writing services to the On Market & Development Organizations.

• Provide support for submission/document updates that are a result of new requirements or product changes.

• Own and recommend division medical writing processes to ensure accuracy and consistency of documents produced.

• Establish partnerships across divisions to support and align with corporate initiatives such as electronic submissions.

• Ensure the review and approval of promotional materials for Abbott marketed products.

• Responsible for keeping current with industry changes relating to advertising and promotion, interpreting new guidance to Industry, and continuing efforts to evaluate processes within Regulatory Affairs relating to the promotion of Abbott products in US and EMEA.

• Negotiates resolution to review findings of ad promo through understanding perspectives of stakeholders and proposing alternate options that would meet the regulatory requirements.

• Lead and direct the preparation of technical/scientific documents such as submissions, package inserts, labels, and clinical brochures for diagnostic assays and instruments (US and international). Manage review/approval and final assembly processes.

• 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.

• Lead departmental and global process improvement initiatives.

• Keep current on changing submission and other document and regulatory requirements and ensure they are incorporated into area activities.

• Proactively seek and evaluate new systems for document creation and management.

Required Qualifications • Bachelors Degree In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred or an equivalent combination of education and work experience, or a Masters Degree

• (In a technical area or M.B.A. is preferred) or an equivalent combination of education and work experience

• Doctorate Degree in a technical area or law is helpful or an equivalent combination of education and work experience

• Experience: Minimum 5 years in a regulated industry

• Minimum 5 years in regulatory preferred in regulatory history, guidelines, policies, standards, practices, requirements and precedents.

• Regulatory agency structure, processes and key personnel.

• Principles and requirements of applicable product laws

• Submission/registration types and requirements · GxPs (GCPs, GLPs, GMPs).

• Principles and requirements of promotion, advertising and labeling.

• International treaties and regional, national, local and territorial trade requirements, agreements and considerations.

• Domestic and international regulatory guidelines, policies and regulations.

• Ethical guidelines of the regulatory profession, clinical research and regulatory process Technical/Business Ability to:

• Monitor costs of projects and of human and material resources within a department or unit.

• Monitor company-wide indicators such as market share and profitability.

• Monitor external environment in area of technical or professional responsibility.

• Understand reimbursement Communication.

• Communicate effect

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