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Intercept Pharmaceuticals
New York, United States
1 day ago

Description

COMPANY SUMMARY:

At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name "Ocaliva ® " in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.

Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.

People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.

At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.

POSITION SUMMARY:

The Senior Manager, Medical Writing will develop and maintain writing timelines, document review/revision responsibilities, maintain department guidelines, SOPs, and the Intercept Style Guide. This position will also collaborate with contractors, CROs, and internal writing staff to ensure all documents within a specific program reflect consistent presentation and messaging. This position will also author, edit, and manage the overall quality of documents within the Medical Writing department. Medical writing deliverables including clinical documents for global regulatory submissions, clinical protocols and study reports, investigator brochures, pediatric investigational plans, and other key clinical and regulatory documents.

CORE ACCOUNTABILITIES:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.
  • Coordinate writing activities and resource planning, including scope of work, timelines, and team member responsibilities.
  • Develop and maintain Intercept Medical Writing Guidelines for protocols, clinical study reports, Investigator's Brochures, and the regulatory style guide.
  • Plan, prepare, write, review, edit, format, and finalize clinical regulatory documents with an emphasis on protocols, protocol amendments and clinical study reports. Support senior writers in authoring of investigator brochures, annual updates to regulatory submissions, other regulatory submission documents (INDs, BLAs, Briefing documents, ad-hoc requests from regulatory agencies, etc.).
  • Serve as a liaison between contractors/CROs and internal cross functional groups (ie, biostatistics, clinical operations, project management, medical affairs, pharmacovigilance, regulatory, and commercial) to ensure all documents within a specific program reflect consistent presentation and messaging.
  • Lead group initiatives in relation to document standards, continuing template development, cross-functional processes and other aspects of document management.
  • Perform peer review of various clinical or regulatory documents.
  • Lead medical writing process development and process improvement initiatives.
  • Ensure compliance, remain informed on regulations and developments in medical writing, and maintain knowledge of product areas, current trends, and current literature.
  • Perform all duties in keeping with Company's core values, policies, and applicable regulations.
  • Other duties as assigned.
  • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
  • Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
  • Make Intercept a truly desired place to work


QUALIFICATIONS:
  • Bachelor's degree in life sciences with 4 years or more direct biotechnology or pharmaceutical industry experience as a medical writer, or advanced scientific degree in life sciences (MS or PhD) with 2-3 years or more biotechnology or pharmaceutical industry experience as a medical writer.
  • Experience in managing contractors or CROs.
  • Prior experience in Hepatology, Gastrointestinal or related field, preferred.
  • Prior experience in contributing to the preparation of clinical protocols, and clinical study reports.

REQUIRED KNOWLEDGE AND ABILITIES:
  • Manage multiple and varied programs with competing and aggressive time lines, prioritize activities, and work independently; Able to work in a quickly changing, not fully structured internal and external environment.
  • Demonstrated record of overseeing the successful planning and implementation of all written components of global regulatory submissions.
  • Excellent editing and writing skills coupled with comprehensive knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the drug development process.
  • Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
  • Proven ability to facilitate issue/comment resolution as it relates to finalization of deliverables.
  • Appropriate computer software experience (including but not limited to Prism, MS Word, Excel, PowerPoint), in particular, document management software; Experience with electronic filings.
  • Strong interpersonal skills; proactive approach.
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies.
  • Strong verbal and written communications skills
  • Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
  • Ability to have fun and thrive in a growing, diverse and inclusive work environment


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Job Information

  • Job ID: 60045951
  • Location:
    New York, United States
  • Position Title: Senior Manager, Medical Writing
  • Company Name: Intercept Pharmaceuticals
  • Job Function: Other
  • Job Type: Full-Time
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