Pharma Doc Specialist

  • Location
    York, Pennsylvania
  • Job type
    Contract/Temp to Hire
  • Salary
    $ 20 - $ 24 / Hour
  • Category
    Information Technology

Pharma Documentation Specialist York PA

* Authors/reviews technical reports as required.

* Develops and provides training for all staff relative to the quality system and general regulatory requirements impacting the

* Effectively utilize resources that are not directly under her/his control to achieve both individual and team goals.

* Interacts with all levels of the Division, Corporate Compliance, Interco Divisions, Dealers, and Customers.

* May manage personnel within group with responsibilities to include coaching, training, and application of policies, programs,

* Performs special tasks and assignments, as required.

* Prepare documents for regulatory submissions in the US, including 510(k)’s. Submit applicable information to Corporate for

* Prepares and submits periodic reports, as required.

* Prepares or assists in the preparation of regulatory strategies/plans and worldwide requirements with partner organizations.

* Provides data in support of business and product information/submissions to inter-company and international partners to

* Provides regulatory support to currently marketed products as necessary.

* Provides updates to SBU on new and changing regulations and determines their effect on our products and business, providing

* Responsible for all worldwide regulatory submissions for Dentsply Sirona Preventive Division, including FDA pre-market

* Review and approval of labeling through Label Review Committee, including UDI requirements.

* Reviews significant compliance issues with manager as necessary, and negotiates submission issues directly with Dentsply

* Supports New Product Development teams, based on market needs, to input into the development process, document and

* Supports the ongoing compliance of the SBU by identifying and correcting gaps in procedures as required and designing and

and procedures. Assures that a positive employee relations environment is maintained through effective communication.

approval, 510K, annual reports, and all amendments, etc. for all regulatory bodies.

enable development of strategies and requirements, and communicates that information to business teams.

guidance on changes required.

implement regulatory strategies, including registration requirements, needed to help facilitate timely launch of new

organization.
presenting training programs to educate associates at all levels within the Division.
products.
 
site registration and device listings, and Canadian registrations.


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Reference number US_EN_99_023348_11946753