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Sr. Manager, Medical Writing

Company: Sarepta Therapeutics
Location: Cambridge
Posted on: March 27, 2020

Job Description:

The Position:

The Medical Writing (MW) Operations Manager will assist the Head of Medical Writing with various operational and administrative tasks related to Medical Writing team processes. In addition, the MW Operations Manager will assist the MW group with other tasks such as editing or formatting documents, helping to create additional operational guidelines for the team, taking notes during team meetings as needed, gathering signatures for clinical regulatory documents, gathering appendices for clinical study reports, helping to resolve technology issues for the group (working with IT as needed), and assisting with contract approvals and vendor management.

Primary Responsibilities Include:

* Assisting with the creation and finalization of operational guidelines such as the steps for document development and tips/best practices for use of our technology tools

* Assisting with scheduling and planning for meetings of the Protocol Approval Committee

* Taking notes and following up on actions from weekly MW team meetings

* Assisting with gathering documents required for completing a submission (whether to a site or Health Authority), such as signatures and appendices (liaising with cross-functional departments)

* Helping to resolve technology issues for the MW team to aid in document creation processes, including staying on top of usage reports from PleaseReview

* Assisting with obtaining contract approvals for MW projects involving outside vendors as well as participating in vendor management and budgeting as needed

* Editing and formatting of Clinical Regulatory documents as needed

Education and Skills Requirements:

* Bachelor s or Master s or equivalent in Life or Health Science discipline

* Project management experience, preferably related to Medical Writing

* Experience leading and/or preparing for recurring team/committee meetings

* 3+ years of medical writing/editing and document processing experience with skills related to technical software troubleshooting

* Knowledge of technical capabilities of Microsoft Office suite of software, Adobe Acrobat, PleaseReview, and document management systems applications

Candidates must be authorized to work in the U.S.

Sarepta offers a competitive compensation and benefit package

Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify

Keywords: Sarepta Therapeutics, Cambridge , Sr. Manager, Medical Writing, Executive , Cambridge, Massachusetts

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