Associate Director, Medical Writing

Position Overview:

The position, reporting to the Senior Director, Head of Global Regulatory Portfolio Management, with 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.

Responsibilities:

• Write or oversee the writing of regulatory submission documents (e.g., clinical protocols, investigator brochures [IBs], clinical study reports [CSRs], eCTD/BLA clinical summaries, and briefing documents for regulatory interactions)
• Maintain timelines and ensure smooth and effective document management from conception to final signature (i.e., generation of a blank document to a final approved version), including management of various processes (e.g., QC, formatting, publishing document)
• Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required to ensure adherence to standards
• Lead or oversee cross-functional document development/review meetings, such as kick-off and comment resolution meetings
• In partnership with Head of Medical Writing, manage outsourcing of document preparation, including writing, editing, review and QC
• Interpret clinical study data as needed for document preparation
• Perform literature-based research to support writing activities as needed

Requirements:

Education and Experience:

• Advanced or bachelor's degree in a scientific discipline; life sciences preferred
• 8 years of experience within the biotechnology/pharmaceutical industry with 5 years of medical writing experience for clinical regulatory documents
• Experience in neuroscience preferred
• Experience managing direct reports, vendors, and/or contract Medical Writers a plus
• Demonstrated experience as a primary author, writing and editing regulatory scientific documents; preparation of protocols, IBs, CSRs, briefing documents for regulatory interactions; and experience on eCTD/IND/NDA/BLA/MAA submission preferred
• Experience with global clinical study/regulatory submissions preferred
• Proven skills of strong document management and project management, along with initiative and ability to be productive with minimal supervision
• Experience in managing multiple projects in a fast-paced environment, with changing priorities and significant time pressures

Competencies and Attributes:

• Demonstrated leadership ability to drive results that are needed to achieve company objectives in accord with Prothena's culture and values – courageous, imaginative, selfless, and joyful
• Exceptional oral and written communication skills
• Ability to build and maintain effective partnerships, both internally and externally
• Flexible; adapts work style to meet organization's 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, Microsoft Office Suite; Project experience a plus)
• Approximately 5% travel is anticipated

Compensation Overview:

The anticipated annual salary range for this role is $180,000 to $230,000. This is 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, as well as 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.