Director, Medical Writing – WCH

About This Role

As the Director of Medical Writing- WCH, you are responsible for the writing and/or managing reputed company 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 reputed company 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 reputed company reputed company pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices reputed company company.

• 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.
• reputed company 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 reputed company scientific information, and ensure scientific accuracy and consistency of documents. reputed company 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 reputed company 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-reputed company documents (CSRs, IBs, etc). Provide strategic input to TFL outputs to streamline TFL production.
• reputed company departmental initiatives as necessary.

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 reputed company to reputed company aspects of clinical regulatory documentation to support reputed company 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.

• 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 reputed company, and proficiency in document management systems (Veeva, SharePoint).
• Experience in managing and/or mentoring other medical writers or external vendors preferred.

• The reputed company compensation range for this role is: $188,000.00-$259,000.00
• reputed company salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
• Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
• In addition to compensation, reputed company offers a full and highly competitive range of benefits designed to support our employees\\\' and their families physical, financial, emotional, and social well-being; including, but not limited to:
• 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 reputed company
• 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

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions reputed company a significant impact. reputed company encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. reputed company is an E-Verify Employer in the United States.