Sr. Director, Medical Writing (Regulatory Affairs)

Location
San Francisco, CA, United States
Posted
Nov 13, 2020
Ref
5264-340-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar is seeking an experienced Sr. Director, Medical Writing to join its Regulatory Affairs team.

This position will lead and oversee the Regulatory Department writing activities for all development projects, ensuring the support of all regulatory submissions to Health Authorities (HA) (FDA, EMA, etc), from pre-IND to post-marketing activities, and most importantly marketing authorization applications (BLA, NDA, MAA, etc.) to help achieve Company goals. The Sr. Director is responsible for the management, planning and direction of a team of medical writers, including contractors, to ensure high quality documents to meet HA requirements/guidelines and to meet project deadlines. Directs the writing, editing and coordination of the review of all key regulatory documents. Works collaboratively with cross-functional teams to support the preparation of regulatory and clinical documentation to global HAs. This role will also include strategic and operational leadership relative to the interpretation of data from development programs for incorporation into regulatory documents. Assists with the recruitment, development and management of personnel.
  • The Sr. Director leads and directs all writing activities for regulatory submissions and provides strategic input as applicable.
  • Reviews documents, offers guidance, and takes lead in mentoring writers in the preparation of regulatory documents.
  • Works with cross-functional team to organize, conduct, and lead regulatory document production meetings, coordination of review/adjudication meetings and other meetings, as necessary.
  • Responsible for the management of budget, timelines and outside vendors/contractors working on regulatory document writing projects.
  • Responsible for developing writing style guide and departmental management system for preparation of regulatory documents for supporting different stages of the drug development, from preIND through to marketing applications and post-marketing submissions.
  • Manages the internal writing staff and their performance, including hiring, training, coaching and performance reviews
A Bachelors/Masters degree in a scientific discipline with a strong scientific background is required. Equivalent experience may be accepted. A PhD in a scientific or life sciences discipline and prior experience in oncology/hematology is preferred. Demonstrated experience as a primary writer supporting regulatory submissions. A minimum of 15 years experience in the pharmaceutical/ biotech industry in a medical writing position is required, including a minimum of 8 years supervisory/management experience of medical writers. Must have an ability to work well with a cross-functional team in a fast-pace environment to meet deadlines. Must have strong organizational and communication (verbal and written) skills, and demonstrated problem solving abilities. Must have proven experience in writing key regulatory documents (eg. briefing packages, BLA/NDA/MAA filing documents, etc.) in CTD format and to meet HA requirements/guidance. Excellent computer skills and high proficiency in using MS word, Excel, Power point are required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.