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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Publishing & Submissions, Operations

Location: United States

Proclinical is seeking a remote Senior Publisher / Regulatory Operations Specialist for a cutting-edge pharmaceutical company.

Must be eligible to work in the US.

Job Responsibilities:

Responsible for the preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND amendments, meeting requests and briefing books
Knowledgeable of eCTD templates and structure of Modules (1-5)
Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions
Assures completeness and quality of submissions from the operations perspective
Identifies issues, suggests and implements solutions
Properly archives regulatory submissions
Knowledge of current regulations, laws and guidance, both US and ex-US
Responsible for interaction with team members across a number of development programs
Keeps track of and manages timelines
Interfaces with project managers, regulatory leads, and/or content authors to provide technical guidance and support in finalizing submission content
Promotes and demonstrates collegiality with all firm members
Participates in the training and development programs

Skills and Requirements:

Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines
A minimum of a BS in Chemistry or Life Sciences
Experience with DocuBridge software, minimum of 3 years is required
A minimum of 3 years pharmaceutical and/or medical device industry experience
A minimum of 3 years of regulatory affairs in FDA regulated products
Expert skills in MS Office, Adobe Acrobat applications, electronic/document/data management systems
Excellent editing and organizational skills
Ability to handle multiple tasks with strong attention to detail
Excellent interpersonal communication skills, both oral and written
Ability to work under strict deadlines and changing priorities

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) 617-963-0342 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-FG1

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