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Sr. Medical Writer

Employer
Santen, Inc.
Location
Emeryville, California
Start date
Nov 20, 2022

View more

Discipline
Clinical, Clinical Documentation, Medical Writing
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health, and addressing vision-related social issues for people around the world. Santen USA, headquartered in Emeryville, Calif., is an important part of our worldwide efforts and is home to our regional business teams. We have about 350 total employees in North America, including our other offices located in Toronto, Canada, Fort Worth, TX and Miami, FL. For more, visit https://www.santenusa.com/.

Job Description

The in-house Medical Writing role is responsible for authoring scientific documents, including protocols, investigator brochures, submission documents, clinical study reports, safety update reports etc. in support of Santen’s development pipeline. The Medical Writing Role will work closely with cross-functional teams to develop high quality and comprehensive medical and scientific clinical trial documents

  • Drive the planning, writing, reviewing, editing, and finalizing of key clinical study and regulatory documentation, including but not limited to protocols, clinical study reports, investigator brochures, clinical regulatory responses, and clinical summaries
  • Provide direction and oversight of activities completed by external/ contract medical writers to ensure timely and quality work product
  • Establish, maintain, and build working relationships with internal and external stakeholders collaborating on clinical documentation development (e.g., KOLs and cross-functional colleagues from Clinical, Medical Affairs, GRA, etc.) to ensure quality, accuracy, and timely inputs for scientific publications
  • Leverage historical protocol learnings to inform future study design; escalate any recurring protocol issues to GCDO leadership
  • Manage protocol amendment process, including authoring and review

Qualifications
  • 5+ years of technical medical writing experience at a biotech or pharmaceutical company
  • Bachelor’s degree in a scientific or healthcare-related discipline; advanced degree preferred; CMPP and/or AMWA certification a plus
  • Expert knowledge of US and international guidance and regulations associated with scientific publications
  • Extensive knowledge of drug development process (phase I-IV clinical trials), GCP, CFR, and ICH regulatory requirements and guidelines
  • Ability to interpret scientific content and adapt to varying audiences
  • Ability to manage medical writing for multiple programs with competing timelines and priorities
  • Working knowledge of statistical concepts and techniques
  • Adept in working in cross-functional and collaborative settings and fosters a learning environment in which colleagues can discuss scientific and medical content

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19. Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit https://www.santenusa.com/career-culture

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Find Us
Website
Location
6401 Hollis Street
Emeryville, CA 94608
US
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