Director/Senior Director, Regulatory Medical Writing

Prothena's success is driven by our people. We are dedicated to attracting individuals who share our vision to improve human health by putting patients first.

But it's not just about what we do at Prothena, it's how we do it. That's why we hire creative and courageous individuals who support one another and are not afraid to try new ideas. Our culture reflects our values which are brought to life every day by the following characteristics:

SELFLESS - Patients come first and we're in this together. Our environment is collaborative and we measure success through our collective accomplishments.

COURAGEOUS - Transformational innovation leads to novel treatments. "Tried-and-true" won't produce breakthroughs for patients – a pioneering spirit, willingness to accept certain risks and to try new approaches. Each Prothenian and functional team is expected to bring their heart, experience and trust on our journey.

IMAGINATIVE - We value and encourage a creative approach across all aspects of our work. We challenge ourselves and each other to think beyond what is known and approach our work through a lens of continuous improvement.

JOYFUL - Humor and heart allow us to tackle the seriousness of our work. Excellence and fun are not at odds – we love what we do and enjoy the journey.

Position Overview:

The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality. This lead medical writer will lead submissions and oversee the selection and management of internal and contract medical/regulatory writers and organizations.

Responsibilities:

• In collaboration with key functional leaders for program teams, including Regulatory Affairs, Clinical Development, Clinical Operations and Research/Translational Sciences, plan, develop, and deliver high quality documents aligned with development program strategies and timelines
• Lead the preparation, review, QC, and finalization of key documents including clinical synopses, protocols and study reports, investigator brochures, modules/sections of INDs/CTAs/BLAs/MAAs, briefing packages and responses to regulatory agency requests, as needed
• In partnership with Head of Medical Writing, manage outsourcing of document preparation, including writing, editing, review and QC by effectively planning, screening, and allocating internal or contract writers to ensure corporate and program objectives are met, in collaboration with global program teams and key functional areas
• Effectively manage the simultaneous preparation of multiple documents within and across development programs at various stages of development to ensure timely document completion in accordance with respective program strategies
• Support Head of Medical Writing to develop and maintain document templates, and ensure consistency between programs, as appropriate. Apply lessons learned across programs to maximize efficiency and accuracy of document preparation
• Participate in process improvement initiatives including medical writing SOPs, templates, style and review guidelines, and other aspects of document management
  
  

Requirements:

Education and Experience:

• Advanced or bachelor's degree in a scientific discipline; life sciences preferred
• 8+ years of clinical regulatory writing experience, preferably with at least 5+ years in a pharmaceutical or biotechnology company focused on novel therapies. Experience in rare diseases and/or neuroscience preferred
• Experience in managing direct reports
• Demonstrated hands on experience in the preparation, review, and completion of key clinical and regulatory documents, including clinical protocols and study reports, investigator brochures, briefing documents, and module 2 summaries
• Supervised preparation of module 2 summarizes/module 5 reports for eCTD/NDA/BLA/MAA submission
• Well versed in ICH guidelines for regulatory submissions (INDs/CTAs/BLAs/MAAs) and associated regulatory documents including clinical protocols/study reports and investigator brochures
• Track record of effective collaboration on project teams, and across multiple organizational levels and functions.
• Proven skills of strong document management and project management, along with initiative and ability to be productive with minimal supervision
  
  

Competencies and Attributes:

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena's culture and values – courageous, imaginative, selfless, and joyful
• Ability to build and maintain effective partnerships, both internally and externally
• Exceptional written and verbal communication skills and attention to detail essential; must display strong analytical and problem-solving abilities
• Excellent planning and organizational skills, including the ability to support and prioritize multiple documents, as needed
• Flexible; adapts work style to meet organization needs
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
• Dedicated to quality and reliability
• Excellent computer skills (Veeva, SmartSheet, Microsoft Office Suite; Project and Visio experience a plus)
• Approximately 5% optional travel is anticipated
  
  

Compensation Overview:

The anticipated annual salary range for this role at the Director job level is $185,000 to $250,000, and at the Sr. Director job level is $220,000 to $300,000. These are the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Benefits, 401(k) and PTO Overview:

• All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums.
• Prothena pays the full premium for basic life and disability insurance for all employees.
• Prothena employees are also eligible to enroll in our Company's 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings and an additional, annual discretionary Company match of up to 2% of eligible earnings.
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays.
  
  

More information about Prothena can be found at the Company's website: www.prothena.com.