CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels 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 Director, Medical Writing Resourcing Group Lead? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.
Position Description Summary:
You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio.
You are the key leadership role in the Clinical Development group, supporting professional development of 5-10 Medical Writing direct reports including providing strategic and tactical leadership and guidance for clinical development activities in projects as assigned across all Therapeutic Areas (TAs).
The Medical Writing Group Lead helps to drive quality scientific and operational clinical development execution, by forming, building and developing a group of talented and committed Medical Writers, collectively delivering timely, scientifically rigorous and high-quality work to meet the needs of Portfolio Development.
Additionally, The Medical Writing Group Lead may provide project related medical writing support as needed.
Main Responsibilities:
Line Management:
• Provides strategic and tactical leadership/guidance to 5-10 TA Medical Writing direct reports as they drive the development of Clinical Development Medical Writing Deliverables, including Investigators Brochure (IB), the Clinical Study Outline, The Clinical Study Protocol (CSP), The Clinical Study Report (CSR) Regulatory Briefing Books, and Submission Documents.
• Drives in the hiring, on-boarding, training and mentoring processes for TA Medical Writers to ensure CSL hires and retains top talent
• Accountable for direct reports performance management, long term career growth, and supports direct reports in the creation of their professional development plan
• Supports creation of effective delivery teams (DTs) in alignment with the portfolio requirements focusing on ensuring that the scientific/medical/technical knowledge as well as industry experience to provide high functioning teams
• Supports direct reports navigate the Project Operating Model to deliver projects in alignment with the PST Strategy
Resource and Budget Management:
• Collaborates with Head of Clinical Sciences and Medical Writing, Director Medical Writing Processes & Standards Group Lead, Clinical Scientist Leads, Global Clinical Leads (GCL)s, and Clinical Development Team (CDT) Leads to ensure adequate resourcing across the portfolio
• Accountable for the Medical Writing group budget and is responsible for providing adequate oversight in accordance with CSL processes and policies
• Accountable for resource allocation management and oversight in Clarity for the Medical Wiring group
• Collaborates with the preferred CRO partners to provide Medical Writing Services across all Tas as needed
Program Deliverables:
• Accountable for the efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including but not limited to the development and maintenance of the IB, the Clinical Study Outline, Regulatory Briefing Books, Module 2 submission Documents for IND, MAAs and BLAs across all therapeutic areas.
• Ensures the establishment of a messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and 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 (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
Qualifications and Experience Requirements:
Bachelors degree in pharmacy, biological sciences or related disciplines is essential.
• 10+ years of medical writing experience within the biopharmaceutical industry or contract research organization.
• At least 3 years' experience in supervisory role.
• Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements.
• Comprehensive understanding of medical writing processes, standards and issues.
• Extensive experience setting up contracts and collaborating with CRO partners to provide medical writing services in an FSP and FSO environment required
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CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
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. Learn more Inclusion and Belonging | CSL.