Posted to MedZilla on 12/2/2017


TechData Services

US-NJ, Medical Writer V


 
 

Duties:


The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed products assigned to obtain company and/or agency approval. Developmental of labeling for these products is based on study results, coordination or labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. The position also includes subject matter expertise in specific labeling regulations (e.g. OTC rules) and review of local labeling to assure compliance with corporate labeling.


Skills:

Knowledge of European and US regulations and international regulatory environment

Knowlegdge of labeling regulations (US, EU and Global)

Experience as labeling manager

Excellent written and verbal communication skills

Negotiation skills



Demonstrated ability to solve problems and proactivity

Ability to work with multifunctional and culturally diverse teams

Organizational skills, ability to manage multiple projects at short notice.

Excellent inter-personal skills

Autonomy

Rigor

Fluent business English.



Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree,


Skills and Experience:

Required Skills:

ORGANIZATIONAL SKILLS

EXCELLENT WRITTEN

EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS

LIFE SCIENCES


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