Senior content professional to elevate B2B brand storytelling across marketing channels. Shape narratives, plan content, and ensure quality.
About the role
- Regulatory Data & Content Specialist ensuring compliance in product development lifecycle within pharmaceutical industry. Assisting with clinical trial protocols and regulatory disclosures, working with cross-functional teams.
Responsibilities
- Be the subject matter expert on product development lifecycle, especially in regulatory functions
- Develop a deep understanding of clinical & regulatory pathways and product development in the pharmaceutical industry
- Assist in posting organizational clinical trial protocols and results on public trial registration websites (ClinicalTrials.gov, EU results registry)
- Identify studies required for registry and results postings and ensure PDR management and staff are aware of timelines and requirements
- Liaise with project teams and affiliates to ensure understanding of regulatory disclosure responsibilities
- Submit protocol documents for registry entries and quality control checks for consistency
- Work with cross-functional team members to gather necessary data and approvals for registry and results postings
- Monitor workflows for timely completion of registry and results entries, ensuring uploads are done on time
- Track and ensure timely responses to correspondence with cross-functional teams and departments
Requirements
- Bachelor's or Master's Degree or Pharm D in Life Sciences, Pharmacy, Clinical Research or equivalent
- 4+ years of relevant experience in the pharmaceutical/biotechnology industry, specifically in regulatory affairs and regulatory writing
- Certification in Regulatory Affairs course is good to have (e.g. PG diploma in Clinical research or regulatory affairs)
- Strong computer skills (Microsoft Office Suite, gSuite, Adobe Acrobat)
- Solid understanding of drug development, and familiarity with regulations and guidelines (e.g. GxP, GCP, ICH) and clinical trial disclosure
- Strong interpersonal and communication skills
- Effective team member in cross-functional and matrix-based environments
- Ability to work under minimal supervision, excellent administrative and project planning skills, detail-oriented, ability to meet deadlines and work under challenging timelines
- Fluency in English (verbal and written) is required.
Benefits
- health insurance
- opportunity to work with innovative technology
- great work-life balance
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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