Director, Senior Expert CoE PI
1881 EMD Serono, Inc. - Rockland, MA

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

PURPOSE OF THE ROLE

Provides statistical, clinical data management and programming for the medical department. Collaborates in the production of the study protocols, provides and/or facilitates sample size calculations. Reviews case report forms (CRFs) to ensure appropriate data collection, cleaning, statistical analysis and reporting of the study. Enhances understanding of statistical hypothesis testing and presentations.

KEY ACCOUNTABILITIES

Functional Tasks
  • leads all labeling-related activities within the product teams (e.g. Regulatory Sub-Team, Labeling Team, Global Project Team) for assigned products with focus on US and medical devices
  • Oversees Creation and maintenance of global Company Core Data Sheets for development and established products in co-operation with the product teams as the basis for worldwide harmonized product labeling documents, with focus on projects/products managed primarily in the US organization
  • Oversees creation and maintenance of US labeling documents in compliance with the Company Core Data Sheet
  • Ensures that consistency between the Company Core Data Sheet and US labeling documents -which are generated under local responsibility- is appropriately documented
  • Co-ordinates response to labeling-related questions from authorities
  • Ensures provision of appropriate support to Regulatory TAs and US Regulatory Head on labeling-related activities
  • Oversees creation and maintenance of minimum text requirements for global Master Packaging as the basis for worldwide harmonized packaging material
  • Provides on request analysis of competitor labeling in the relevant therapeutic area
  • Maintains awareness of local and regional labeling requirements- focus on US
  • Liaises with US Regulatory Intelligence and other functions to identify regulatory labeling initiatives for as early as possible. When such initiatives are identified, supports development of a company position on evolving labeling-related regulations, as well as development of an implementation plan.
  • Participates in creation of labeling-relevant Quality Documents and guidelines
  • Develops proposals for company comments to regulatory initiatives and guidelines
  • Trains product teams on labeling-relevant Quality Documents, guidelines and working processes
  • Participates in authority meetings as appropriate
  • May serve as delegation head for health authority meetings
  • Develops relationships with other regulatory professionals, associations and authorities
  • Serves and is recognized as an expert in one or more relevant non project specific areas of expertise for the company e.g. Labeling expertise for medical devices, biosimilars
  • May represents the company on external forums
STRATEGIC IMPACT
  • Built and establish a CoE PI expertise focusing on therapeutic areas and global products managed in US
  • Oversees creation and maintenance of Global Regulatory Product Information (labeling) documents with special focus on US
  • Drives the harmonization of labeling of assigned products in conjunction with global and US medical and regulatory functions
  • Analyses new regulations with focus on US labeling and develop strategies to meet these. Drives the implementation of Labeling strategies in the CoE PI unit to achieve harmonized processes.
SCOPE OF PEOPLE RESPONSIBILITY

Managerial Tasks
  • Builds and manages a CoE PI unit, ensuring adequate staffing levels to meet resource needs and adequate trainings.check
  • Acts as mentor to dedicated staff to the CoE PI unit
  • Takes care of functional resources, including recruitment, deployment, and professional development, and performance evaluation of a Labeling unit
  • Creates an environment that attracts, develops and retains high quality employees
COOPERATION

Interfaces with other Departments/Functions:
  • Other GRA functions, US Regulatory Head, US CMO, Head of US Labeling, Promotion & Commercial Regulatory Compliance group.
  • Other functions within GDDM (particularly functions represented in the Labeling team)
  • Other functions outside GDDM (e.g. Global Marketing, BUs)
External Interfaces:
  • Affiliates
  • Health Authorities
  • External Scientific and Regulatory Experts
  • CROs

Qualifications

CANDIDATE’S PROFILE

EDUCATION
  • MD, PharmD or PhD degree or comparable education in a scientific discipline.
  • Fluent command of spoken and written English
  • Knowledge of German and/or French desirable, depending on location
  • Knowledge of Spanish or other languages welcome
WORK EXPERIENCE
  • 8 or more years experience in pharmaceutical industry in regulatory affairs, pharmacovigilance, medical information or clinical development
  • At least 5 years labeling experience with proven knowledge in global US or EU labeling requirements and related processes
  • 3 or more years experience in leading and managing teams in pharmaceutical research & development organizations
JOB-SPECIFIC COMPETENCIES & SKILLS
  • Ability to understand and manage in a multi-cultural environment
  • Proven leadership, project management and process improvement abilities
  • Excellent interpersonal communications, organizational, and presentation skills
  • Superior negotiation and influencing skills
  • Ability to travel nationally and internationally
ADA REQUIREMENTS
  • Normal and routine office duties
  • Position requires both domestic and international travel up to 25% of time
Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination .

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