Director, Scientific Communications

  • Location
    Los Angeles, California
  • Job type
    Direct Hire
  • Category
    Medical & Science - Pharmaceutical - Clinical

The Director of Scientific Communications will be responsible for leading a team of medical writers in developing both regulatory documents and scientific publications in support of oncology clinical studies and marketed products.

Responsibilities include, but are not limited to: preparing and managing high-quality regulatory documents for FDA submission; planning and implementing strategic scientific publication efforts; establishing relevant SOPs and guidelines to support the efforts of a growing Scientific Communications department; and managing competing project priorities in a dynamic startup environment. This position reports to the Senior Vice President of Medical Affairs.

Responsibilities:

Coordinate and manage development of regulatory documents (protocols, IBs, CSRs) for FDA submission.
Develop and implement strategic publication plan for creating, coordinating, and tracking scientific publication materials (manuscripts, abstracts, posters, and slide presentations).
Develop and implement SOPs to ensure that publication activities are aligned with strategic initiatives and industry best practices.
Work closely with cross-functional teams to develop and implement strategic publication plans for regulatory submissions and scientific manuscripts.
Grow, manage, and develop a medical writing team that includes onsite and remote medical writers.
Drive and/or support scientific content development for regulatory documents and scientific publications.
Ensure quality, consistency, alignment, and compliance of regulatory documents and publications.

Required qualifications:

Advanced degree (MD, PhD, or PharmD).
Minimum of 5 years professional experience as a medical writer, including a minimum of 3 years’ experience in leadership roles.
Demonstrated expertise in writing, editing, and managing both regulatory documents (clinical study protocols, IBs, CSRs) and scientific publications (abstracts, manuscripts, poster presentations).
Ability to manage KOLs as external authors.
Understanding of good publication practices and guidelines, ie, ICMJE, GPP3, etc.
Familiarity with AMA style guidelines.
Knowledge of FDA, EMA, and ICH guidelines.
Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
Excellent communication, time management and project planning skills.
CMPP and/or AMWA certification preferred.
Disciplinary expertise in oncology and immunology preferred.


If you are interested in thisDirector, Scientific Communications job in Los Angeles, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at randy.williamson@adeccona.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled


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Reference number US_EN_2_108175_330542