Director, Medical Writing, Oncology

Job Function:
Medical Affairs Group
Job Sub Function:
Medical Writing
Job Category:
People Leader
All Job Posting Locations:
Allschwil, Basel-Country, Switzerland

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for Director, Medical Writing, Oncology.

United States - Requisition Number: R-040736

Belgium & Netherlands - Requisition Number: R-055919

United Kingdom:

• Requisition Number: R-055926

Switzerland:

• Requisition Number: R-055927

Canada:

• Requisition Number: R-055928

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose:The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools.

You will be responsible for:

• Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals.
• Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles.
• Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions.
• Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence.
• Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments.
• Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently.
• Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration.
• Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members.
• Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed.
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems.
• Participate in industry standards working groups to represent MW and ensure alignment with best practices.
• Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU)
• Head and in line with R&D priorities and TA objectives.
• Recognized expert medical writer for any document within and across TAs.
• Accountable for MW resource management and allocation within their portfolio(s).
• Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority.
• Can step in for DU Head in case of absence.
• Is a major contributor to multiple deliverables for the function, TA, or DU.
• Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
• Responsible for creating an environment where employees feel engaged and empowered, and
• take pride in their role, responsibilities, and deliverables.

• Takes on additional major responsibility with mínimal supervision, operating at an expert level with accountability for the highest levels of quality:

• o Cross-