Director, Medical Writing - WCH

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.

• 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.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation