Sr. Director, Global Head of Medical Writing/CTT

MerckBillerica, MA
Hybrid

About The Position

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. As the Global Head of Medical Writing, you will shape and lead a high-performing, global function that sits at the heart of clinical development and regulatory success. In this pivotal senior leadership role, you will build, develop, and manage a team of over 100 medical writing professionals, driving the delivery of timely, high-quality clinical documentation across a complex and fast-moving global portfolio. You will set the strategic direction for medical writing standards, processes, and tools, ensuring the organization remains at the forefront of regulatory science and documentation excellence. Working in close partnership with clinical, regulatory, and vendor management stakeholders, you will translate organizational priorities into operational plans that consistently deliver results at scale. This is a rare opportunity to leave a lasting impact on how a global medical writing function operates, innovates, and elevates the quality of science that ultimately serves patients worldwide.

Requirements

  • Advanced degree in a scientific or writing discipline (Master’s or PhD).
  • At least 12 years of relevant Medical Writing experience in the pharmaceutical/biotech industry.
  • A minimum of 5 years established track record managing large medical writing teams within global, matrixed organizations.
  • Ability to travel as needed.

Nice To Haves

  • Demonstrated skill and engagement in state of the art medical writing tools.
  • Established track record driving the adoption of modern tools to facilitate efficient and effective medical writing.

Responsibilities

  • Responsible for building, leading, and managing the Global Medical Writing Team (5-10 direct reports, Total staff >100)
  • Identify project staffing requirements, develop and maintain staffing plans to meet project demand
  • Ensure the delivery of timely and high-quality MW deliverables according to global project plans
  • Work closely with vendor management to ensure implementation of operating model and delivery to contracts
  • Oversee the preparation of strategies documents prepared by Medical Writing Leads
  • Identify gaps in skills and drive continuous improvement
  • Develop clinical documentation processes that ensure consistency and control
  • Oversee and ensure standards for clinical documents are developed, used and maintained.
  • Ensure the company follows state of the art standards / regulations / tools in medical writing activities
  • Oversee, coach and supervise vendors to ensure milestones meet timelines and deliverables are of high quality

Benefits

  • health insurance
  • paid time off (PTO)
  • retirement contributions
  • other perquisites
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