Scientific (Medical) Writing Lead

2 hours ago
Full-time
Lead
Project and Program Management
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001

Description

  • Lead the Scientific Writing team and provide day-to-day coaching, guidance, and operational support.
  • Plan and coordinate team tasks, resources, and required information for project execution.
  • Serve as the primary point of contact for medium- to high-complexity Scientific Writing projects.
  • Own content and scientific strategy for complex projects.
  • Draft, review, and update SOPs, Working Instructions, Job Descriptions, and related documents.
  • Write, review, and assess a broad range of scientific, clinical, and regulatory documents.
  • Evaluate documents for marketing authorisation of medicinal products, clinical studies, and other biomedical research, and prepare conclusions and recommendations.
  • Contribute to regulatory strategy and the clinical research program.
  • Participate in audits and support related documentation and responses.
  • Prepare or support financial proposals, service orders, agreements, and regulatory budget planning.
  • Communicate and coordinate with vendors, consultants, and key experts.
  • Provide backup support to other team members when needed.

Requirements

  • MSc or higher degree in Medicine, Pharmacy, Public Health, or Life Sciences.
  • PhD is preferred but not essential.
  • At least 5 years of experience in medical or scientific writing.
  • Previous mentoring or line management experience is preferred.
  • Strong scientific background.
  • Fluency in a native language and English.
  • In-depth knowledge of the clinical development process, regulatory procedures, and relevant industry guidelines.
  • Good understanding of basic human anatomy and physiology.
  • Basic knowledge of biostatistics.
  • Scientific writing competency.
  • Proficiency with MS Word, Excel, PowerPoint, Outlook, and reference management software.
  • Strong attention to detail and ability to prioritize work and meet deadlines with high quality.
  • Ability to work independently and collaboratively within a team.

Benefits

  • International team and working environment.
  • Professional growth and career opportunities.
  • Annual performance-based bonus.
  • Additional bonus system through Instant Reward and Recognition program.
  • Personal accident and business trip insurance.
  • Additional health insurance.
  • Workplace establishment allowance for fully home-based employees.
  • Influenza vaccines.
  • Referral reward policy.
  • Remote work possibility with flexible working hours.

Interested in this position?

Apply directly on the company website

Apply Now

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