Senior Publisher/Regulatory Operations Specialist - REMOTE
Proclinical is seeking a remote Senior Publisher / Regulatory Operations Specialist for a cutting-edge pharmaceutical company.
Must be eligible to work in the US.
- 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 firstname.lastname@example.org.
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.