6 jobs found in Wayne, PA

  The Principal Medical Writer is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development.   The incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the 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. This role has global responsibilities, participation in global teams and interaction with regulatory agencies in multiple regions....

Reporting to the   Head , Global   Clinical Development  t he Global Clinical Lead   (GCL)   will act in a key leadership role in the   C linical   D evelopment   (CD)   group;   Providing s trategic and tactical   M edical   & Scientific   leadership and guidance for clinical development activities for 5-8   Global Clinical Program Leaders ( GCPL )   Serving as the CD   representative on the   Therapeutic Area Leadership team (TALT)   for   CVR   TA   May   act as any of the following roles in clinical development:   G CPL , Early Clinical Development Lead, B usiness   D evelopment (BD)   C ontributor , Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead   as appropriate for   p rojects as   assigned per business need   Main Responsibilities and Accountabilities:     GCL Line...

The Role: Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.  Manages  case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility. Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities; Supports the preparation and conduct of PV and other GxP inspections and audits, as required, . Establishes, maintains, and/or ensures maintenance of  clinical trial case management required documents, such as safety reporting plans and reporting responsibilities  , in line with international and national regulations, guidelines, and internal standards. Oversee the Vendors to ensure GSPV...

The Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy, drives process excellence, and oversees the delivery of clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs.  All activities and deliverables must be conducted in alignment with international regulations, CSL policies, industry standards and transparency requirements. Key Responsibilities Strategic Oversight & Compliance Lead enterprise clinical trial disclosure and transparency strategy and advise therapeutic areas and Medical Affairs on...

The Opportunity: The Senior Director, Medical Affairs, Hematology Pipeline is a senior-level global leadership role responsible for architecting and executing the end-to-end Medical Affairs pre-launch and peri-launch strategy for a high-priority hematology asset. This role serves as the primary Medical Affairs point of accountability for pipeline readiness, leading a team of four direct reports across US and International regions and collaborating extensively with cross-functional enterprise partners. The successful candidate will bring deep hematology expertise, launch experience, and the strategic acumen to translate scientific evidence into compelling, compliant medical narratives that position the asset for successful market entry. The Role: Global Pre-Launch & Peri-Launch Strategy: Lead the design and execution of a comprehensive global Medical Affairs pre-launch plan, ensuring alignment across US and International regions and readiness for peri-launch...

CSL's 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 Associate Director, Medical Affairs (Transplant and Immunology)? The job is in our King of Prussia, PA or Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director, Medical Affairs, Transplant & Immunology. You will contribute to the development of medical strategy for assigned inline products in Transplant & Immunology and drive the execution of Medical Affairs plans across the post-launch product lifecycle.   Working in close collaboration with cross-functional partners and engaging effectively with external thought leaders, the role...