Job Description Summary As head of the Regulatory Submissions Management organisation, you will line-manage the RSM team members worldwide, as well as overseeing the outsourced publishing programme. Taking day-to-day oversight of Publishing, workload planning and associated processes, you will be the key contact on relevant topics for all customer groups, as well as advising the Head of Regulatory Operations on GE's future publishing strategy.

Job Description GE Healthcare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Essential Responsibilities

• You will manage the team day to day, and plan workload across the internal RSM team and external publishing partner 
• You will identify, sponsor, manage, and/or actively participate in projects related to publishing standards and LEAN process initiatives
• You will monitor resource levels internally and externally and act accordingly
• You will oversee publishing tool upgrade and maintenance projects
• You will also monitor agency guidance, changing regulations and upcoming initiatives and take appropriate action.

Qualifications/Requirements

• Educated to Bachelor's Degree level or equivalent experience
• Extensive experience of hands-on eCTD Publishing and Submissions Management principles is essential, with knowledge of standards and processes in all eCTD regions (EU, US and RoW)
• Hands-on experience with eCTD Publishing and PDF manipulation software as well as Document Management and RIM systems (e.g. Veeva Vault)
• Previous team management experience essential
• Experience working with outsource partners also an advantage.

Desired Characteristics

• Strong interpersonal skills and ability to forge connections with colleagues at all levels
• Ability to clearly explain concepts and technical information as well as providing training and mentoring to new starters
• Good presentation skills
• Ability to identify problems and their solutions, as well as driving them to resolution, delegating where necessary to achieve results
• Excellent IT skills, with the ability to learn new tools and systems quickly.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
 
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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Additional Information Relocation Assistance Provided: No