Minnnesota Bioscience Jobs

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DOCS Senior Publisher (Medical Writer) in St. Paul, Minnesota

Senior Publisher (Medical Writer)

Ref #: 27118

Employment type: Permanent - Full-Time

Location: US-Remote

Posted: 19-Mar-2021

Description

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

POSITION OVERVIEW/SUMMARY

Under the direction of the Senior Manager, Regulatory Publishing, the Senior Publisher will publish regulatory submissions (NDA/IND/NDS applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing documents and general correspondence), ensuring timely submission of high quality, compliant and valid submissions in eCTD format to the FDA and Health Canada within required timeframes. This position will also have a critical role in ensuring documentation is formatted according to company standards (templates, style guide).

KEY RESPONSIBILITIES

Formats submission documentation for eCTD compliance.

Provides project support in the remediation of submission documentation such as formatting documents to ensure consistency within and between documents and with document templates.

Creates submission application in docuBridge, publishes submission contents as fully compliant, validated electronic submissions.

Contributes to new and updated processes and standards.

Participates in validation testing of new and upgraded software.

Monitors new and updates to regulatory policies and guidance relating to electronic submissions from various regulatory authorities and other applicable agencies and/or professional organizations.

Ensures quality control (QC) of all documents received by RA publishing.

Works with document preparation authors to ensure documents are ready for publishing.

Maintains all applicable regulatory files, and source documents used to create filings for assigned investigational and/or marketed products.

Maintains an advanced working knowledge of FDA regulatory guidance and policies.

Assists with the development of best practices that conforms to regulatory requirements for eCTD publishing.

As applicable, provides expertise to project teams on the application of electronic submission requirements for specific submissions.

Coordinates with departments on content and submission deliverables for assigned projects.

Maintains working knowledge of global and local electronic submission guidelines.

Contributes to process improvement initiatives across the organization.

Assists with other regulatory activities as required.

QUALIFICATIONS

Minimum BA/BS or equivalent work experience in life sciences, computer science or related field

Minimum of 3-5 years relevant work experience with strong background in the pharmaceutical industry in a reporting or compliance-related function

Experience with CDER and/or IND, BLA, NDA regulatory submissions

Advanced experience with eCTD publishing tools, preferably docuBridge; ISI Toolbox

Advanced experience with electronic document management systems

Advanced knowledge of FDA regulatory guidance and policies regarding eCTD submissions

Strong communication (written and verbal) skills

Detailed oriented, organized, quality driven and able to work in a team environment under tight deadlines

Proficiency in MS Office (Excel, PowerPoint, Access, Outlook) with extensive experience in Word, Adobe Acrobat and Documentum

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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