Senior Medical Writing Director

hace 4 semanas


Barcelona, Barcelona, España Mymenopauserx, Llc A tiempo completo

Empower the Future of Medicine at Mymenopauserx, Llc

At Mymenopauserx, Llc, we are seeking an experienced Senior Medical Writing Director to drive the creation of high-quality clinical regulatory documents and support the development of our clinical portfolio.

Your Impact:

  • Strategize and Lead: Drive the development and execution of document strategies for regulatory submission, ensuring the highest quality of clinical study protocols, reports, and Investigator's Brochures.
  • Collaborate and Contribute: Play a key role in developing briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents.
  • Ensure Excellence: Author and manage outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines.
  • Communicate Consistently: Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling.
  • Mentor and Direct: Mentor and Direct medical writing team members to ensure efficiency and quality in document production.
  • Innovate and Collaborate: Develop effective partnerships within Mymenopauserx, Llc and with external stakeholders to maintain adherence to industry standards and regulatory requirements.

What You Bring to the Table:
  • Experience: At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise.
  • Communication Skills: Exceptional oral and written communication abilities, with proficiency in MS Office.
  • Regulatory Knowledge: A deep understanding of global regulatory requirements and ICH/GCP guidelines.
  • Leadership: Proven experience managing and mentoring medical writers and fostering the development of junior staff.
  • Professional Ethics: A strong sense of responsibility, ethics, and respect for others.
  • Work Environment: Ability to work in an office environment, utilizing computers and participating in communication and collaborative activities during standard business hours.

What we offer:
  • Flexible Health Benefits: a flexible benefits program for comprehensive health and dental care.
  • Retirement Savings: Employees receive an automatic employer Pension contribution and can contribute to the Optional Savings Plan, which attracts an additional company match.
  • Flexible Extras: We offer extras to support employees and the big moments in life. From great maternity, parental and adoption leave support, to increased paid bereavement days, and our 12-week top-up for compassionate and critical illness leave.
  • Vacation: a minimum of 4 weeks of paid vacation, pro-rated to your date of hire.

Why Join Us?
At Mymenopauserx, Llc, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
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