Associate Director, Medical Affairs Operations

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.  For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.  Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence.  Our success is a direct result of our outstanding employees.  We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team.  While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive.  We believe engaging on a day-to-day basis, in person,  builds solid and lasting relationships, and contributes positively to our culture and innovation.  From the heart of our stunning Carlsbad campus,  we aim to provide a central connection point for all our employees.  These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow.   Join us and experience our unique culture while you develop and expand your career. 

ASSOCIATE DIRECTOR, MEDICAL AFFAIRS OPERATIONS 

SUMMARY: 

The Associate Director of Medical Affairs Operations is a member of Ionis’ Medical Affairs department, reporting to the Director of Medical Affairs Operation. This position will play an integral role in supporting Ionis Pharmaceuticals as it transitions into and operates as a fully integrated biotechnology company (FIBCo). The primary responsibility of the Associate Director of Medical Affairs Operations will be operational management of the Medical Material, (MMRC) process for non-promotional materials used externally by Ionis in accordance with FDA regulations, ICH guidelines, and PhRMA guidelines. The role will also support other key Medical Affairs activities may include medical information operations, field medical operations, budget planning, congress planning, and grants and sponsorships.   

RESPONSIBILITIES: 

• Create, maintain, and administer policies, procedures, user guides, and training for the MMRC process and the electronic approval system (EAS).
• Collaborate with MMRC reviewers and escalation committee members to provide guidance and direction, answer questions, and resolve issues related to the MMRC process.
• Coordinate and/or oversee the coordinator of the MMRC process to facilitate documents through review and approval ensuring alignment with Ionis processes and industry standards and effective material lifecycle management.
• Serve as the business owner of the EAS to oversee system maintenance, enhancements, integrations, user licenses, and resolve issues in partnership with Informatics. 
• Track and report relevant metrics to monitor the performance efficiency of the MMRC process and implement corrective actions to address inefficiencies. 
• Forecast MMRC process volumes to enable appropriate resource allocation.
• Select, contract with, and oversee vendors providing support to the MMRC process (i.e., coordinator, submissions support, quality review).
• Serve as the operations lead to support to the Head of Medical Information on implementation, integrations, and enhancements of processes and systems (e.g., Medical Information System) to ensure effective compliant operations.
• Serve as the operations lead to support to the Head of Medical Information in vendor oversight of call centers to ensure compliant and appropriate handling of medical information and clinical trial requests.
• Serve as the operations lead for the Field Medical Team to support process and system implementations for effective compliant daily operations including, but not limited to, KOL Management Platforms, Customer Relationship Management (CRM) Platform, and the CRM/EAS integration.
• Provide operational and/or technical capability support to other Medical Affairs activities as needed (e.g., KPIs/Metrics, audit readiness, clinical trial call center management, congress activities, event planning, grants, and sponsorships, print management,).

QUALIFICATIONS: 

The individual who will be successful in this role will have existing experience with Medical Affairs operations and specifically non-promotional or promotional material review processes and systems. The individual must also be highly organized, self-motivated, approachable, and an articulate team player who has the highest level of integrity and core value system consistent with our culture and core principles.  

 REQUIREMENTS: 

• Bachelor’s degree with 6+ years’ OR Master’s degree with 4+ years’ progressive operational experience in the biopharmaceutical industry preferable Medical Affairs
• 2+ years direct experience in non-promotional or promotional material review processes and systems; preferable Veeva Vault MedComms or Promomats.
• Experience collaborating with internal teams to create and implement standardized SOPs.
• Experience communicating with organizational leadership to facilitate change management across an organization.
• Demonstrable project management skills: proven ability to manage multiple tasks to conclusion, within allotted timelines/deadlines, and without compromise to quality of work.
• Knowledge of project management tools and experience using collaboration tools such as SharePoint and Smartsheet.
• Proven organizational skills with experience managing multiple priorities.
• Strong attention to detail and ability to work independently.
• Exceptional verbal and written communication skills.
• Solid interpersonal and teamwork skills, and a strong work ethic. 

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003310

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $162,245 to $206,749

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.