Essential Duties and Responsibilities
Oversees and leads scientific, medical, and regulatory writing activities for all development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities. Ensures the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches. Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data. Serves as liaison between all clinical functions to assure consistent messaging around products company-wide. Provides strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental and operational issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive level management and key operational leaders, requiring negotiation of extremely difficult matters to influence policymaking bodies. Directs all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents and offers guidance in the preparation of regulatory and publication documents. Organizes, conducts, and leads document production meetings and other meetings as necessary. Projects Medical Writing budget, resource, and timeline requirements for CDP. Manages timeline, budget, and outside vendors on regulatory document writing projects. Develops and manages Departmental Guidelines management system, Writing style guide, and departmental templates such as protocols, investigator''s brochures, final clinical study reports, and IND sections. Provides and manages internal and external writing activities. Develops department infrastructure such as establishing style guides and generation of templates and processes. Manages internal staffing and performance management, including hiring, training, coaching, and performance reviews. Remains current with relevant medical developments and publications on similar and competitor products and applies this knowledge to current programs. Ensures the development and implementation of clinical program strategy and directs those systems and programs in order to meet Company objectives.
Additional Qualifications
Demonstrates experience as a primary author writing regulated scientific documents. Knows regulatory functions, FDA and ICH guidelines, and CTD format for various scientific documents. Possesses strong analytical and strategic thinking skills with the ability to implement. Creates effective presentations from raw data. Interprets statistical and clinical data. Works well with others in high-pressure situations. Demonstrates problem-solving abilities. Possesses strong organizational skills. Communicates effectively in oral and written form. Understands clinical research, biostatistics, and regulatory affairs. Has experience writing clinical protocols, investigator brochures, clinical study reports, and IND/NDA sections. Possesses good computer skills and knowledge of Omnicia software and MS Word, Excel, PowerPoint, and Outlook.
Education or Degree Requirements
A Bachelor''s/Master''s degree in a scientific discipline with a strong journalism background. PhD in a scientific or life sciences discipline preferred.
Minimum Professional Experience
15 years in a pharmaceutical, biotech, or CRO medical writing position. 10 years writing management experience. 12 years previous supervisory experience.
Additional Information
Nektar currently anticipates the base salary for the Sr. Director, Medical Writing to range from $280,000 to $320,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company''s discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
Health Insurance (Medical/Dental/Vision)
Disability Insurance
Holiday Pay
Paid Time Off (PTO)
401(k) Match
Employee Stock Purchase Plan
Wellness Programs
Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.