Summary: Seeking a Medical Writer with a focus on clinical reports and regulatory submissions in a remote capacity.

Job Requirements:

Must have a Bachelor's Degree

Proven experience in writing, editing and reviewing regulatory documents such as Clinical Evaluation Reports, clinical study reports, summaries, Summary of Safety and Clinical Performance, Periodic Safety Update Report etc.

Experience in conducting proofreading, editing, document formatting, review comment integration and document completion/approval activities

Preferred Skills:

Familiarity with Post Market Surveillance activities including monthly literature review of our product

Experience collaborating with cross-functional teams to ensure high quality and successful project delivery

Ability to create and manage project schedules for each clinical evidence document

Job Responsibilities:

Write, edit and review regulatory documents and responses to Notified Bodies

Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities

Collaborate with principal investigators, statistical and clinical communications teams on formulating first drafts of manuscripts

Perform Post Market Surveillance activities including monthly literature review of our product

Collaborate with cross-functional team to assure high quality project delivery

Manage applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.

 

 Pay: 30-40

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

 

 

Pay Details: $30.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.