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.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking an Associate Director, Medical Writing. This position resides within Clinical Development with the overall responsibility and accountability of Medical Writing activities as it relates to the generation of regulatory documents. This position is responsible for working with project teams to produce complex clinical documents for global regulatory submissions, including summaries and overviews, clinical protocols, clinical study reports, investigator brochures, pediatric investigational plans, clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents. This position also provides expertise and leadership. The Associate Director of Regulatory Medical Writing manages internal medical writing staff and external medical writing agencies/consultants and will liaise with key internal and external stakeholders to ensure the seamless development and execution of regulatory documents. The position represents Medical Writing on the project teams across the company's portfolio, providing oversight and coordination of medical writing deliverables for Clinical, and partners with internal and external groups to ensure quality, compliance, and promote innovation in writing deliverables.
The successful candidate must be able to perform each of the following satisfactorily:
- Responsible for planning, preparation, writing, reviewing, editing, formatting, and finalizing regulatory documents to support clinical pharmacology and clinical programs.
- Documents include, but are not limited to, global submission documents (NDAs, MAAs, sNDAs), INDs, briefing documents, clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, and other regulatory submission documents (eg, ad-hoc requests from regulatory agencies, etc.).
- Coordinate writing activities for project teams, including timelines and document review/revision responsibilities; Cross-functional collaboration with regulatory, biostatistics, clinical operations, project management, medical affairs, pharmacovigilance, regulatory, and quality assurance.
- Participate in development of clinical and regulatory submission strategies and regulatory interactions.
- Serve as medical writing representative on project teams and advise teams on content, format, and formatting requirements for documents.
- Perform peer review of various clinical or regulatory documents.
- Leads group initiatives in relation to document standards, continuing template development, cross-functional processes and other aspects of document management.
- Lead medical writing process development and process improvement initiatives.
- To ensure compliance, remain informed on regulations and developments in medical writing, and maintain knowledge of product areas, current trends, and current literature.
- Identify, assess, and oversee individual contract and temporary writers.
- 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
Experience and Skills
- An advanced scientific degree in the life sciences with 8 years of experience or PhD/MD with 5 years or more direct biotechnology or pharmaceutical industry experience as a medical writer and proven management experience.
- Prior industry experience in leading the preparation of clinical modules of NDA and MAA documents, as well as briefing documents. Multiple NDA/MAA's preferred.
- Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal, Metabolic Syndrome, or related field, preferred.
- Previous supervisory experience preferred.
REQUIRED KNOWLEDGE AND ABILITIES:
- Excellent 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.
- Demonstrated record of overseeing the successful planning and implementation of all written components of global regulatory submissions.
- Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
- Demonstrated record of contributing to the successful planning and implementation of a publication plan; Able to manage key opinion leaders as external authors.
- Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables.
- Appropriate computer software experience (including but not limited to Prism, MS Word, Excel, PowerPoint), in particular, document management software; Experience with electronic filings.
- Manage multiple and varied programs with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing, not fully structured internal and external environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies; proactive approach.
- 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