JOB DESCRIPTION:The OpportunityThe 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 OnThe 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 effectively verbally and in writing.
- Communicate with diverse audiences and personnel.
- Write and edit technical documents.
- Work with cross-functional teams.
- Work with people from various disciplines and cultures.
- Write and edit technical documents.
- Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies.
- Negotiate internally and externally with regulatory agencies and participate in political lobbying.
- Plan and conduct meetings.
- Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks Cognitive.
- Pay strong attention to detail.
- Manage projects.
- Create project plans and timelines.
- Juggle multiple and competing priorities.
- Think analytically with good problem-solving skills.
- Organize and track complex information.
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Exercise good and ethical judgment within policy and regulations.
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
Preferred Qualifications- Minimum 3 years management experience
- Minimum 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.
- 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 division products desirable
- Excellent written and oral communication skills.
- Superior attention to detail.
- Computer fluency in word processing, flow diagrams, spreadsheets, and project management software.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
The base pay for this position is $129,300.00 - $258,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:AMD Molecular
LOCATION:United States > Itasca - AMDC : 1015 West Devon Ave
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday)
