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 CSL
Your 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, etc
* High level of self-awareness and the awareness of personal impact
* Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
* Succinct, concise and clear communication style
* Extensive experience of leading teams and/or line managing a group(s)
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.