WHO YOU ARE:

In addition to having exceptional written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have strong regulatory writing experience and strong teamwork capabilities. You have expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4), and acts as a medical writing subject matter expert to other departments. You have a demonstrated management, scientific, and customer-focused leadership skills.

REQUIRED SKILLS

• Minimum of BSc + 12 years’ experience in Medical Writing, or Advanced degree + 7 years’ experience in Medical Writing (pharmaceutical, biotechnology, or CRO setting)
• Experience with global regulatory submissions (e.g. BLA/NDA, MAA)
• Familiarity with eCTD format and relationships between documents.
• Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents.
• Proven experience authoring documents and leading teams through the authoring process.
• Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
• SME in MS Word, and proficiency in document management systems (Veeva, SharePoint).
• Experience in managing and/or mentoring other medical writers or external vendors preferred.

ABOUT THIS ROLE:

As the Director of Medical Writing- WCH, you are responsible for the writing and/or managing complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development. You are also responsible for providing direct supervision for the Medical Writing program leads, including response to potential Medical Writing issues with internal cross-functional teams and external development partners. You will contribute to the long-term growth strategy of the department and ensure that standard procedures are followed across and within projects. You will synchronize prioritization of projects and in some cases, he/she represents Medical Writing in meetings with governance committees, regulatory agencies, and external development partners. Performs outreach within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company.

WHAT YOU’LL DO:

• Have the knowledge and be independently able to prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions. Thorough understanding of industry best practices to strategically design documents that fulfil their purpose but written with public disclosure requirements in mind.
• Lead the planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements. Support the development and maintenance of SOPs and templates for document development.
• Ability to critically analyze and synthesize complex scientific information, and ensure scientific accuracy and consistency of documents. Develop and integrate messaging and medical writing strategy and ensure consistency through documents in a therapeutic area and/or disease state.
• Collaborate with cross-functional SMEs including (but not limited to), Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations.
• Participate in regulatory submission planning, timelines, and document development.
• Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables. Mentor and provide professional development guidance to junior writers. May serve as the MW liaison for one or more Functional Service Providers (FSP)
• Provide mentoring and career development to direct reports to create a high-quality and productive group.
• Review statistical analysis plans and clinical data reports that are incorporated in data-related documents (CSRs, IBs, etc). Provide strategic input to TFL outputs to streamline TFL production.
• Lead departmental initiatives as necessary.