Scientific Program Manager

Overview

We are seeking a Scientific Program Manager to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference.

 

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. 

 

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

Responsibilities

• Oversee all regulatory submission publishing deliverables on a day-to-day basis to ensure successful execution of operational activities, including IND and MF submissions to the US FDA.
• Work independently to drive publishing process for both original IND and IND maintenance submissions, and proactively identifies and escalates publishing issues, as necessary.
• Edit and format regulatory documents, document publishing, regulatory submission compilation and QC, and eCTD dossier submissions to the US FDA using Liquent InSight Publisher, LORENZ publishing tool or equivalent software.
• Perform regulatory document level publishing, including editing, formatting (MS Word: styles, captions, cross-references, tables, etc.), conversion of files to required standards, Adobe PDF processing: book marking; hypertext linking; and quality control checks.
• Perform end-to-end submission assembly/publishing, including eCTD placement and structure within eCTD Modules (1-5), cross-document links, study tagging files (STF), submission quality control (QC), transmission of submissions to US FDA via Electronic Submissions Gateway (Liquent Insight Publisher and Liquent Validator or equivalent software).
• Maintain proficiency and expertise with respect to eCTD publishing tools, processes, and regulations associated with global eCTD regulatory submissions. Advise the regulatory science team on best-practice submissions requirements.
• Develop publishing processes and documentation (SOPs, work instructions, toolkit documents and presentations), including user acceptance testing for new and updated publishing tools.
• Liaise with the NIAID contract publishing team as needed to manage routine submissions workload.
• Guide associates in eCTD regulatory submissions.

Qualifications

• Bachelor's degree or foreign equivalent in Regulatory Affairs, Life Sciences, Computer Science, Information Technology, or related field.
• A minimum of 5 years' recent experience in publishing/Regulatory Operations in the biotechnology or pharmaceutical industries. Document formatting experience (MS Word and PDF) a plus.
• In-depth working knowledge of industry standard publishing systems and desktop applications, including MS Word and Adobe Acrobat Professional.
• Expertise in eCTD publishing and US FDA regulatory submissions standards.
• Mastery of eCTD Word and PDF document formatting. Knowledge of formatting tools (e.g., ISI Toolbox, EX-Author, Adobe Pro DC Toolbox) is a plus.
• Excellent communication and interpersonal skills.
• Ability to multi-task, pay close attention to detail, and follow projects through to completion. Excellent organizational, prioritization, and planning skills, including the ability to adapt to changing priorities and deadlines.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

 

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

 

Employment is contingent upon successful