Medical Affairs Lead Gastroenterology

UCB Atlanta , GA 30301

Posted 4 months ago

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

Gastroenterology Medical Strategist (GMS)

The GMS is responsible for developing and executing ecosystem-specific medical strategies aimed at ensuring the relevance of UCB's immunology clinical value proposition. The GMS is also accountable for leading strategic medical engagements with key decision-makers within large medical groups and IDNs to enhance UCB's ability to: 1) effectively communicate unmet needs for patients and health systems in their management of chronic inflammatory disease, 2) engage with UCB's clinical value proposition, and 3) generate actionable medical insight .

This position will support our Gastroenterology franchise in the Immunology Patient Value Unit (iPVU).

Major Accountabilities and

  • UCB is currently seeking a talented individual as Gastroenterology Medical Strategist as part of the Gastroenterology Core Team based in Atlanta, GA.

  • Critical responsibilities included, but are not limited to:

  • Coach and model high impact medical engagement, delivery and differentiation of gastroenterology value proposition to key immunology ecosystem decision-makers Lead and contribute to local ecosystem medical strategy and resource development with internal medical support to generate innovative immunology clinical value proposition content. Coach and model development of strategic partnering relationships with key immunology executive population stakeholders

  • Lead and model a deep understanding of medical influencers in each ecosystem

  • Lead strategy and development of Opinion Leaders

  • Lead role in developing a medical education plan as well as training and providing clinical/scientific updates to speakers' bureau members. Team lead for organizing regional advisory boards including developing agendas and content.

  • Lead role in developing a Payer slide deck for field use with key accounts.

  • Lead Role in material design, review, and representation of GI Core Medical Strategy in interactions with Legal, Compliance, Review Committee and Medical Affairs

  • Communicating economic and value proposition education to internal and external stakeholders

  • Partner and lead in concert with Sales Leadership, IEPLs, and Outcomes Specialists to create strong internal and external working relationships that define, and coordinate local strategic imperatives

  • Operates at the highest level of UCB compliance and professional standards. Compliance is a part of how we operate within UCB. Adherence to compliant behavior is an expectation at UCB and demonstrated by embracing ethical decision-making practices and guidelines in all aspects of our organization

Education Requirements:

  • Doctorate Degree (PharmD, MD, DO, or PhD in a relevant field required)

  • 3 years of medical management experience in industry. Autoimmune disease or biologics experience preferred

  • 3 years of relevant therapeutic area (Gastroenterology) experience

  • Demonstrated success in planning and executing market shaping medical strategies in support of clinical value propositions

  • Demonstrated strength in strategic medical planning, tactical plan development and execution

  • Demonstrated experience and documented success leading teams in cross-functional matrix environment

  • Strong proficiency in understanding large medical group/IDN and health plan healthcare models

  • Demonstrated line leadership skills in managing, developing, and influencing teams

  • Demonstrated excellence in written and verbal communications

  • Valid US Driver's License and no more than three moving violations in past 2 years

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system or the central nervous system.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a 'can-do' attitude can thrive. Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do thingsthese are some of the key competencies we are constantly developing, and looking for, at UCB.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Staff Regulatory Affairs Specialist

Stryker Corporation

Posted 1 week ago

VIEW JOBS 10/5/2019 12:00:00 AM 2020-01-03T00:00 Job Description Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division to be in Mahwah, NJ or remotely anywhere in the US. Who we want * Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues. * Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. * Communicators. Articulates well and expresses ideas effectively. * Learners. Great desire to learn and looks to continuously improve. * Teammates. Supports, encourages, and inspires others. What you will do As the Senior Staff Regulatory Affairs Specialist, you will bring and sustain products on the market via pre-market submission activities with global Health Authorities. You will operate in a fast-paced environment and you will liaise with internal and external customers and establish strong relationships with Health Authorities. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You will provide leadership and guidance to junior Regulatory Affairs professionals. * Possess and apply advanced knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance. * Review progress with management; assist Management in training RA Specialists, Senior, or Staff Specialists as required. * Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.). * Assist in the development of regulatory strategy and update strategy based upon regulatory changes. * Evaluate proposed products for regulatory classification and jurisdiction. * Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. * Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines. * Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. * Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies. * Provide regulatory input and technical guidance on global regulatory requirements to product development teams. * Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process. * Demonstrate developing technical leadership skills interdepartmentally. * Evaluate medical device regulations and develop strategies for bringing products to market. * Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market. * Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support. * Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. * Provide regulatory information and guidance for proposed product claims/labeling. * Monitor the progress of the regulatory authority review process through appropriate communications with the agency. * Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools. * Assess global impact of changes to launched products and support notifications/submissions as required. * Review labeling and marketing literature for compliance with regulatory requirements. What you need * A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. * A minimum of 7 years of experience in an FDA regulated industry required. * A minimum of 5 years of Regulatory Affairs experience required. * RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. * Experience authoring regulatory submissions for product approval and interacting with regulatory agencies required. * Proven ability to develop, author and implement global regulatory strategies for new products. * Ability to comply with constantly changing regulatory procedures and prioritize work effectively. * Ability to analyze and resolve non-routine regulatory issues using independent judgment. * Excellent analytical and writing skills. * Excellent interpersonal, written and oral communication skills. * Effective organizational skills. * Advanced PC skills with proficiency in Microsoft office Suite, including Excel. Work From Home: Yes Travel Percentage: Up to 25% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Stryker Corporation Atlanta GA

Medical Affairs Lead Gastroenterology