Senior Manager, Publications

Location
Emeryville, CA, United States
Posted
Dec 24, 2020
Ref
1043
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

COMPANY DESCRIPTION:

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talents to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Senior Manager, Publications, a part of the Global Medical Affairs (GMA), develops, deliver, and manages Global Scientific publications across assigned therapeutic areas and molecules/products throughout the product lifecycle. This work encompasses Global publications and congress medical affairs booth planning, medical materials development, scientific education activities for external and internal audiences, and vendor management. The Senior Manager works closely with the therapeutic area medical leads and cross-functional partners across the organization in collaboration with the regions. This role ensures all timelines are met or exceeded and is responsible for process quality, efficiency, and consistency. The position reports to the Director of Global Publications in GMA.

RESPONSIBILITIES:

 

  • In collaboration with the therapeutic area medical leads, develops, maintains, and adjusts global publication strategies and imperatives detailing the appropriate scientific. communication across the assigned company portfolio and product lifecycle marketed and investigational products to relevant external audiences.
  • Develops key scientific and communication objectives by having a strong scientific knowledge of the assigned therapeutic areas and molecules/products to drive credible, fair balanced, timely scientific publications.
  • Coordinates and leads internal cross-functional publication team meetings and activities and external Medical Publications Steering Committees.
  • Effectively and consistently communicates the publication strategy, tactics, and plan progress to internal business partners.
  • Coordinates collaboration with authors, ensuring compliant author engagement; manages author meetings to facilitate content discussion and ensure appropriate content development process is followed.
  • Reviews manuscripts, abstracts, and poster/slide content for accuracy and scientific rigor by having an in-depth knowledge of the scientific content; manages and facilitates the internal and external content review processes, including review and adjudication of comments.
  • Masters and maintains up to date knowledge of ICJME and GPP 1-3 and Santen publications policy requirements; applies them in daily activities, including strategy development, tactical execution, and committee management.
  • Acts as liaison between Medical Affairs Publications and external scientific content contributors.
  • Develops and maintains tools and processes, including efficient and effective tracking systems (e.g., DataVision) for publication activities.
  • Coordinate and manage agencies and vendors across all aspects of publications, congress planning, and scientific content development.
  • Acting as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions.
  • Managing assigned budgets to ensure consistent compliance with agreed parameters.

 


MINIMUM REQUIREMENTS:

 

  • Advanced degree in Scientific Discipline or applicable Health Sciences field (e.g., PharmD, PhD, MD) is preferred.
  • Minimum of 6 years relevant pharmaceutical/biotechnology industry experience, with 3-5 years of publication planning experience within the pharmaceutical/biotechnology industry including submission processes for publications.
  • Ophthalmology therapeutic area experience is preferred.
  • Knowledge of pertinent external guidelines related to industry publications, and current standards of good publication practice.
  • Experience with clinical trial reports and data presentation and interpretation preferred.
  • Excellent communication, presentation, and negotiation skills.
  • Strong interpersonal and partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams.
  • Demonstrated experience of successfully influencing cross-functionally, cross-culturally, and cross-brands.
  • Strong project and process management skills: proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and tasks through to successful conclusion.
  • Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources.
  • Awareness and understanding of regulatory guidelines (FDA, PDMA, PhRMA, etc.) and how they apply to scientific communications and medical education.
  • Ability to travel up to 25% domestic and internationally to attend scientific congresses and relevant meetings.