Manager, Regulatory Publishing

Company: ICON Strategic Solutions
Location: Nashville
Posted on: January 27, 2023

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.Position overview:As a Manager of Regulatory Publishing you will work within one of PRAs key client partnerships assuming people (functional) management responsibilities for a small team of experienced Publishers, and combining this with hands-on publishing and support in the development of global regulatory submissions to Health Authorities.With oversight of publishing and support deliverables, you will provide expertise to your team, and be responsible for workload assignment, training, performance management, recruitment and onboarding, professional development and coaching.In addition to your team management responsibilities, your other key tasks will include:

• Acting as the product-aligned primary publisher for global regulatory submissions (including eCTD, NeES and paper formats), setting the strategy for the submission
• Planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submissions forecast and managing timelines and quality
• Liaising with other stakeholders, including Regulatory Affairs, Submission Managers and functional authors to define and agree submission requirements and timelines
• Interpret regulatory guidelines and regulatory documentation practices to ensure compliance
• May also serve as Subject Matter Expert for various publishing tools or dossier types and mentor staffAs a Manager, you may also work on departmental initiatives, process improvement, validation testing or highly complex submissions. You will also participate in the leadership of the publishing team and serve as a more senior point of contact for the client.You are:Enthusiastic, independent, results-driven, accountable with a flexible and positive approach.Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
  • Extensive experience in regulatory publishing across Europe or globally
  • The ability to adapt to new ways of working and learn new processes
  • Experience with eCTDXpress, ISI Publisher and / or Liquent Insight Publisher is preferred but not essential
  • Previous experience in people management (preferred)
  • A strong understanding of regulatory requirements and submission processes
  • Fluency in English
  • Ability to motivate and use tact, diplomacy,
  • Demonstrated leadership ability, with strong negotiating and influencing skills.
  • Ability to manage complex projects and timelines.
  • Ability to identify and understand complex issues and propose creative and achievable solutions.
  • Strong attention to detail and accuracy.
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels
  • Ability to cultivate internal and external relationships.
  • Applicable knowledge of the drug development process.
  • Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
  • Bachelors degree in a relevant field of study or equivalent applicable experienceBenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Keywords: ICON Strategic Solutions, Nashville , Manager, Regulatory Publishing, Advertising , Nashville, Tennessee