Labeling Strategist (m/f/x) (Global Labeling Strategy Lead)

 

Passion for Innovation. Compassion for Patients.

 

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

 

 

 

We are seeking highly qualified candidates to fill the position of:

 

Labeling Strategist (m/f/x) (Global Labeling Strategy Lead)

 

The Position:

This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late-stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on strategic and operational decisions.

This role could be filled Europe-wide, in one of the Daiichi Sankyo office locations (excluding Belgium and Greece), on site, hybrid or remote by design. Please visit our website for more information on our office locations.

Roles and Responsibilities:

• Acts as point of contact for cross-functional teams on global labeling issues

• Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU

• Preparation of updated Core Data Sheets, and EU and US Documentation: 

• Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PL, CCDS)

• Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment

• Strategizes and plans for FDA meetings as needed

• Acts as point of contact for cross-functional teams on RA labeling issues

• Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.

• Ensure Compliance with Core Data Sheets/Label Changes: 

• Manages updates to Core Data Sheets for assigned products

• Manages US/EU and local country labeling deviations from CCDS

• Ensures implementation of CCDS/labeling agreements with licensing partners

• Conduct Label Review Committee Meetings: 

• Prepares documents for review by labeling teams

• Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations

• Ensure Compliance with Labeling Regulations and Guidance: