Senior Director, Head of Medical Writing

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Senior Director, Head of Medical Writing? The job is in our King of Prussia, PA Waltham, Maidenhead UK, Melbourne Australia or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.

Your role :

The incumbent will be responsible for the quality and delivery of high-quality clinical development documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and training development of the medical writing specialists in the group.

Your responsibilities will include:

Oversight of Individuals Recruiting, staffing, training and development of medical writing specialists in the group, to maintain a dynamic and cutting-edge level of scientific expertise.

Ensuring delivery of high-quality clinical development content including:

Provision of medical writing services to support the clinical development, clinical safety and regulatory requirements of our clinical programs. Includes forecasting, budgeting, resource planning and resource allocation

Efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including the provision of a consistent product messaging strategy

Establishment of a messaging strategy across a program of work, for the provision of strategic input into documents such as submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency

Provision of medical writing services to support publications from CSL’s clinical programs (namely primary and secondary publications)
Development, oversight and delivery of Quality Controls to assure high-quality documents.

Development and implementation of processes and templates to support consistent and high-quality of all documents

Develop a strategy for incorporating technologies to enhance and improve delivery of medical writing content (eg, AI tools)
Support collaboration with CSL’s CRO partners through participation in relevant oversight committees

Internal interfaces and collaboration:

Member of the Clinical Development Leadership Team Will be responsible for managing a team of approximately 15 Medical Writers.

Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Biometrics, Research, GRA & Safety to assure an effective project related delivery

Participate and/or lead enterprise initiatives

Maintaining effective oversight of quality in conjunction with appropriate Quality functions

Strong partnership with CROs to enhance medical writing needs​External-scientific:

Enhancing the reputation of the Company through a culture of scientific integration of the department with the Medical Writing community and other partners through visible presence at relevant societies conferences, membership of consortia and similar medico-scientific groups, builds networks with experts in the field

Ensures that the patient and health-care provider voice is integrated into CSL’s development mindset

Building a culture of urgency, quality, innovation and peer review across the clinical function:

Providing medical writing leadership throughout CSLYour skills & experience:

Graduate level degree (M.Sc, PhD, MD etc)10 yrs+ of Pharma experience in clinical development

Experience across all phases of development, FIH, POC, late-stage development and life cycle management.

Strong track record of successful medical writing leadership

Experience across a wide range of regulatory document writing e.g. protocols, CSRs, CTDs, Briefing Documents, etcHigh level of self-awareness and the awareness of personal impact

Enhanced organizational awareness and the ability to…