Senior Labeling Associate

hace 4 semanas

Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

Job Summary:

The Senior Labeling Associate will be responsible for executing the content management of non-complex local product documents, Local Label Documents, and Patient Leaflets for nationally registered products across multiple countries/regions.

Key Responsibilities:

  1. Contribute to the completion of moderately complex projects under the direction of more senior labeling managers.
  2. Utilize regulatory knowledge to produce non-complex LPDs, LLDs, and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow.
  3. Produce other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables, and annotated supportive documentation.
  4. Provide QC support to other labeling colleagues.
  5. Identify incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
  6. Meet defined targets on productivity, quality, and compliance, as set by and overseen by management.

Requirements:

  1. Strong knowledge/understanding of the principles and concepts of labeling.
  2. Strong knowledge of key regulatory and labeling principles and local regulations.
  3. Proficient in use of systems consistent with business expectations, and understands the importance of systems in maintaining high compliance figures.
  4. Fluency in English and Spanish languages.
  5. Clear and effective written and verbal communications.
  6. Understanding of the importance of Standard Operating Procedures (SOPs), systems, and processes in underpinning quality and compliance of deliverables.

Qualifications:

  1. Life sciences, pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.
  2. 'Hands on' registration experience associated with development, maintenance, and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy.
  3. Ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment, and practical management of associated impacts is preferable.
  4. Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post-approval (maintenance) stages is preferable.
  5. Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
  6. Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
  7. Demonstrated project management, attention to detail, and problem-solving skills required.
  8. Proven technical aptitude and ability to quickly learn new software, regulations, and standards.

Work Environment:

The Senior Labeling Associate will work in a hybrid environment.

EEO (Equal Employment Opportunity) & Employment Eligibility:

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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