Director, Medical Writing Resourcing Group Lead

CSL Plasma•Waltham, MA

11d•Hybrid

About The Position

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 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.

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

Responsibilities

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
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
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.