Corbus Medical Writing is a collaborative team who is responsible for preparing clinical regulatory documents to support development programs throughout the product lifecycle. Medical Writers are key members of study teams and submission teams.
The Director/Associate Director will be a strategic, hands-on medical writing expert with responsibility for building, leading and managing a team of writers and for preparing high-quality clinical regulatory documents. The Director/Associate Director will contribute both strategic and operational perspectives. The Director/Associate will make significant contributions to department initiatives and will collaborate with key functions across the organization.
· Advise teams on the content and presentation of clinical regulatory documents
· Participate as a member of team involved in defining the direction of the clinical development program or regulatory strategy
· Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objectives
· Optimize interdisciplinary understanding and integrate activities with those of other departments and project teams
· Predict and plan resource requirements and staffing needs, ensuring appropriate staff are available to meet program goals
· Participate in developing and implementing processes and templates to ensure efficient preparation of high quality medical writing deliverables
· Provide input to strategies and tactics for Medical Writing
· Oversee hiring of staff; provide coaching and performance management
SKILLS & REQUIREMENTS:
· PhD (or equivalent degree) preferred, and 7+ years of relevant work experience
· Experience authoring clinical regulatory documents
· Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
· Experience managing direct and indirect reports, including medical writing contractors
· Ability to plan, manage, and optimize resources
· Strong leadership and influencing skills
· Attention to detail
Corbus is a close-knit team of over 150 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist rationally designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer