Director, Medical Writing Resourcing Group Lead Job at CSL Plasma in Waltham

Overview

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 are 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 role is in King of Prussia, PA; Waltham, MA; Maidenhead, UK; or Zurich, Switzerland. This is a hybrid position and onsite three days a week.

Position Description Summary

You will be responsible for providing medical writing services to support clinical development by managing the Medical Writing budget project and the functional budget, and by ensuring the medical writing team is resourced appropriately to meet the portfolio demands.

You are the key leadership role in the Clinical Development group, supporting the professional development of 5-10 Medical Writing direct reports, including providing strategic and tactical leadership and guidance for clinical development activities in projects across all Therapeutic Areas (TAs).

The Medical Writing Group Lead helps drive quality scientific and operational clinical development execution by forming, building and developing a group of talented Medical Writers who collectively deliver timely, scientifically rigorous and high-quality work to meet Portfolio Development needs. Additionally, the Medical Writing Group Lead may provide project-related medical writing support as needed.

Main Responsibilities

• Line Management: Provide strategic and tactical leadership to 5-10 TA Medical Writing direct reports as they drive the development of Clinical Development Medical Writing Deliverables, including Investigator's Brochure (IB), Clinical Study Outline, Clinical Study Protocol (CSP), Clinical Study Report (CSR), Regulatory Briefing Books, and Submission Documents.
• Drive hiring, onboarding, 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 support in creating their professional development plans.
• Support creation of effective delivery teams (DTs) aligned with portfolio requirements, focusing on scientific/medical/technical knowledge and industry experience to provide high-functioning teams.
• Support direct reports in navigating the Project Operating Model to deliver projects in alignment with PST Strategy.

• Resource and Budget Management: Collaborate with Head of Clinical Sciences and Medical Writing, Director Medical Writing Processes & Standards Group Lead, Clinical Scientist Leads, Global Clinical Leads (GCLs), and Clinical Development Team (CDT) Leads to ensure adequate resourcing across the portfolio.
• Accountable for the Medical Writing group budget and for providing adequate oversight in accordance with CSL processes and policies.
• Accountable for resource allocation management and oversight in Clarity for the Medical Writing group.
• Collaborate with preferred CRO partners to provide Medical Writing Services across all TAs as needed.

• Program Deliverables: Ensure efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including development and maintenance of the IB, Clinical Study Outline, Regulatory Briefing Books, and Module 2 submission documents for INDs, MAAs and BLAs across all therapeutic areas.
• Establish a messaging strategy across a program of work for strategic input into clinical development plans and submission plans, and for analyzing proposed plans, programs, or studies to ensure they deliver the information required by target audiences (regulatory authorities) with accuracy and consistency.

Qualifications and Experience Requirements

Bachelor's 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 in a supervisory role.
• Comprehensive understanding of medical writing for clinical development, including required documents at each stage and 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/FSO environment.

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Our Benefits

CSL employees who work at least 30 hours per week are eligible for benefits effective day 1. We support employee wellbeing with resources and benefits from healthcare to financial protection to help you focus on meaningful work. Our benefits cover various life stages and needs.

Please review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global biotherapeutics leader focused on serving patients’ needs through innovative therapies in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas. We use three scientific platforms—plasma fractionation, recombinant protein technology, and cell and gene therapy—to support continued innovation and address unmet medical needs.

CSL Behring operates one of the world’s largest plasma collection networks. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to patients in more than 100 countries.

Inclusion and Belonging

At CSL, Inclusion and Belonging is at the core of our mission. We celebrate differences and foster curiosity and empathy to better understand and connect with patients and donors, building a diverse workforce for the future. Learn more about Inclusion and Belonging.

Do work that matters at CSL Behring!