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Medical Writer

Newark Metro Area, New Jersey

Post Date: 04/21/2017 Job ID: JN -042017-18886

Description:
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
o Demonstrated ability to solve problems and proactivity
o Ability to work with multifunctional and culturally diverse teams
o Organizational skills, ability to manage multiple projects at short notice.
o Excellent inter-personal skills
o Autonomy
o Rigor
o Fluent business English.

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


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