Sr. Medical Writer / Module 2 / Pharma Regulatory submissions (REMOTE-WORK)

Pioneer Data Systems Inc
Published
October 8, 2021
Location
Collegeville, PA
Category
Job Type

Description

Our client, a world-leading Pharmaceutical Company is currently looking for a Sr. Medical Writer / Module 2 / Pharma Regulatory submissions (REMOTE-WORK) to join their expanding team.

Position Details:

Job Title: Sr. Medical Writer / Module 2 / Pharma Regulatory submissions (REMOTE-WORK)

Duration: 6 months contract, extendable up to 18 months

Location: R emote Worker

Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the comp any group medical insurance plan

Description:

The Medical Writer (Senior Manager/Associate Director) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.

Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.

Applies advanced knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.

Is facile with innovative problem solving and peer influence.

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