Head of IFU Management US Core Lab
Listed on 2026-07-06
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Management
Regulatory Compliance Specialist, Program / Project Manager, Operations Manager, Change Management
Head of IFU Management, US Core Lab
The position leads, inspires, and develops a high‑performing team of approximately 10 technical writers at the Indianapolis site. Our Product Information teams ensure that customers worldwide receive precise, timely, and compliant documentation. Your mission is to guarantee that the Instructions for Use (IFU) for our US portfolio are delivered with top‑notch quality, on time, and within budget—optimally supporting both business‑critical product launches and key product lifecycle changes.
You will actively help shape the next generation of product information by driving digital innovations (such as AI) and process optimizations.
- Shaping the Future of Content:
As a key member of the Product Information Leadership Team, you align operational processes in Indianapolis with our global strategic goals and digital transformation roadmap. - Driving Global
Collaboration:
You establish a cross‑site culture, break down silos, and actively leverage synergies between our international locations to boost innovation and operational efficiency. - Leading Through Innovation:
You are a driving force for continuous improvement, establishing data‑driven decision‑making and integrating cutting‑edge technologies into local workflows. - Team Empowerment:
You create an inclusive environment where exceptional results are the standard, taking full disciplinary and functional leadership of your team (including performance management and development) and fostering a culture of psychological safety. - Excellence and Compliance:
You ensure that all product documentation strictly complies with legal guidelines and regulations while meeting the evolving needs of our US customers. - Budget Management:
Responsible for the budget planning and compliance of your unit.
- Education:
A successfully completed degree in Technical Communication, Business Administration, Life Sciences, or a comparable field. - Leadership
Experience:
5+ years of experience leading and developing high‑performing teams (preferably 10+ people) with a proven track record of fostering a culture of psychological safety, accountability, and continuous growth. - Industry Expertise:
Sound experience in technical writing, content management, or IFU management, ideally within the medical device, diagnostics, or pharmaceutical industry. - Pioneer Mindset: A "pioneer" mindset with experience leading teams through digital transformations, navigating ambiguity, and actively driving new ways of working.
- Project Management:
Strong project management skills with a focus on data‑driven decision‑making to balance "quality on time" with long‑term process optimization. - Communication & Stakeholder Management:
Excellent communication and stakeholder management skills to operate successfully across cultures and time zones. Fluency in English is a given for this role.
The expected salary range for this position based on the primary location of Indiana is:
Base Pay Range: $103,100 - $191,500 Annual. Actual pay will be determined based on experience, qualifications, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long‑term incentive program. This position also qualifies for the benefits detailed at the link provided below.
Location:
Indianapolis, IN
Relocation:
Relocation benefits are not available for this posting.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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