Sr. Medical Writer Position Available In Middlesex, New Jersey

Job Description:

Tris Pharma, Inc. (www.trispharma.com) is a leadingprivately-owned U.S. biopharmaceutical company with a focus ondevelopment and commercialization of innovative medicines in ADHD,spectrum disorders, anxiety, pain and addiction addressing unmetpatient needs. We have more >150 US and International patentsand market several branded ADHD products in the U.S. We alsolicense our products in the US and ex-US markets. We have a robustpipeline of innovative products spanning neuroscience and othertherapeutic categories employing our proprietary science andtechnology. Our science and technology make us unique, but it isour team members that set us apart; they are the engine fuelingTris’ passion and innovation. Our colleagues understand thecriticality of operating a successful business and take pride inthe company’s success. But of equal importance to each team memberis how we interact with one another on a daily basis. We believe ineach other and in respectful, open and honest communications tohelp support individual and team success. We have an opening in ourMonmouth Junction, NJ facility for an experienced SR. MedicalWriter. This is an individual contributor role. SR. Medical Writerprovides advanced medical writing expertise and leadership in thepreparation of clinical and regulatory documents. Collaboratingclosely with cross-functional teams to ensure accuracy and clarityof scientific content, the incumbent contributes to development ofresearch protocols and supporting regulatory submissions. She/heplays a crucial role in advancing organization’s researchobjectives and improving patient outcomes. Prepares and reviewsclinical and regulatory documents including, but not limited to:

New Drug Applications (NDAs), study protocols, clinical studyreports, investigator brochures, regulatory submissions, etc.

Ensures accuracy, clarity and consistency of scientific content inall documents Collaborates with clinical researchers,biostatisticians and other stakeholders to gather and interpretdata Contributes to research protocol and amendment developmentSupports regulatory submissions by preparing high-quality documentsmeeting regulatory requirements Stays current with industrystandards/advancements in medical writing and regulatoryrequirements Provides medical writing guidance and supportscross-functional teams (i.e., clinical development, regulatoryaffairs, biostatistics, external vendors, etc.) Oversees, and worksindependently on, medical writing projects ensuring timely andaccurate completion Requirements

QUALIFICATION REQUIRED

Bachelorsdegree and minimum 10 years experience in medical writing in thepharmaceutical, biotechnology or related healthcare industryMasters or PhD in a scientific discipline (i.e., Life Sciences,Medicine, Pharmacy)

PREFERRED

Previous experience working with NDAsand other regulatory submissions Knowledge of regulatoryrequirements and guidelines for clinical trials Proficiency inmedical writing software and templates (i.e., EndNote, StartingPoint, etc.) Experience with data management and quality assuranceprocesses We are a HYBRID work environment requiring candidates tobe able to come into office periodically or as needed. Thisposition also requires limited domestic and international travel,on occasion. Tris Pharma, Inc. offers a highly competitivecompensation and benefits package. To build and enhance our diverseworkforce, we encourage applications from individuals withdisabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma,Inc. is an Equal Opportunity Employer. LI-hybrid