Senior Regulatory (eCTD) Publisher/Client Liaison – Top $$/ Direct Hire
Our client, a niche provider of specialized services to support the pharmaceutical and biotech industries, is actively recruiting for a highly skilled and knowledgeable Regulatory Publishing specialist to assume key role on its client services team.
Client is prepared to pay industry-leading wage to attract and retain the right candidate.
Things to Note:
- This company provides a wide range of drug development support, with particular focus on Regulatory Affairs and Medical Writing Services.
- This Senior Regulatory Publisher will be responsible for leading assigned Regulatory Operations projects. This is a hybrid role that will involve regulatory publishing tasks as well as project management and client relations responsibilities. Seek broadly-skilled candidate who thrives a point-person role.
- Role will involve compiling and publishing global regulatory submissions in eCTD format. In-depth knowledge of submission and publishing requirements, practices and operations (including eCTD software) is expected.
- This is a highly collaborative environment. Right candidate will be an effective partner in a cross-functional setting. Ability and desire to pitch in where needed will be important.
- This is an office-based role with occasional flexibility to work from home.
This Senior Regulatory Publisher will be responsible for the preparation of submission-ready components and publishing of global regulatory submissions. He/she will be interface with both clients and colleagues to ensure that information is collected, prepared and submitted in a timely, compliant and persuasive manner.
- Provides MS Word and PDF document formatting support to ensure consistency with company and health authority submission ready standards
- Reviews documents and liaises with contributors to address deficiencies and provide guidance related to requirements for electronic submission
- Compiles and publishes high-quality electronic regulatory submissions in eCTD format utilizing publishing software
- Acts as primary contact for the assembly and transmittal of regulatory submissions
- Conducts and/or participates in the final review of publish-ready submissions to ensure compliance to regulatory standards and requirements for electronic submissions
- Collaborates with internal team members to assure standard practices and quality submission deliverables
Targeted candidate will offer a related degree and 2+ years of directly-related experience in regulatory submissions, ideally in a publisher role. Other priorities include:
- Strong knowledge of MS Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
- Knowledge of global regulatory requirements with a strong focus on US, EU, ICH requirements.
- Outstanding organizational and project management skills
- Exceptional attention to detail
- Polished written and verbal communication skills
Finally and importantly, we seek a skilled client service professional who enjoys partnering with client liaisons, understanding their needs and expectations and ensuring exceptional service delivery. This client prides itself on its outstanding reputation for excellence. Seek quality-driven candidate who will extend that reputation.
This is a Direct Hire role and an immediate need. Please forward Word resume for prompt consideration. Local candidates only.