Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Senior Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to serve as a senior contact in providing innovative solutions, including regulatory expertise. As a Senior Regulatory Affairs Specialist, you'll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.
As a trial transparency liaison you’ll be responsible for leading and overseeing the transparency activities on a CTT level: protocol registration, result posting and redaction of CTIS documents and supporting IDT-level transparency activities: anonymization and/or redaction of post-marketing approval documents.
What You’ll Do:
- Manage and coordinate the global disclosure and transparency (CTT) deliverables in accordance with the company transparency policy:
- Initiate and maintain clinical trial registration in various global trial registries (i.e., Clinicaltrials.gov and CTIS).
- Lead and coordinate the result posting in various global trial registries.
- Manage and coordinate the redactions of the CTIS documents, including the identification of commercially confidential information (CCI).
- Maintain an in-depth knowledge of the fast-evolving global transparency and disclosure regulations.
- Provide support and/or lead transparency activities as directed.
- Assist transparency efforts and operations.
- Prepares and reviews regulatory submissions.
- Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
- Leads the development and implementation of project-specific processes for sponsors.
- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
- Provides training and guidance to junior team members as appropriate.
- Participates in project launch meetings, review meetings and project team meetings.
- Supports business development activities, including project budgeting/forecasting.
- undefined
- Education and Experience Requirements:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 3+ years of experience in clinical trials, experience in a transparency position (protocol registration, CTIS redaction, clinicaltrials.gov) is a plus.
- Experience in and understanding of global clinical trial transparency regulations.
- Familiarity with clinical trial documents and knowledge of clinical study and clinical development design.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Strong English language (written and oral) communication skills as well as local language where applicable
- Solid attention to detail and quality as well as strong editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments - Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Solid negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other
- global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
- Solid understanding of medical terminology, statistical concepts, and guidelines
Strong analytical, investigative and problem-solving skills - Working knowledge of budgeting and forecasting
- Working knowledge of Adobe Acrobat Pro.
- High learning attitude and adaptability.
- Multi-tasks and prioritize effectively in fast-paced environment.
- Highly self-motivated and independent.
- Leader skills to oversee the CTT transparency activities
- Team player who seeks to help and learn from colleagues seeing the department success as their own.
- A problem solver and critical thinker that relies on own judgment for appropriate level of decision making.
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.