Sr. Medical Writer

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced SR. Medical Writer. This is an individual contributor role.

SR. Medical Writer provides advanced medical writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to ensure accuracy and clarity of scientific content, the incumbent contributes to development of research protocols and supporting regulatory submissions. She/he plays a crucial role in advancing organization's research objectives and improving patient outcomes.

• Prepares and reviews clinical and regulatory documents including, but not limited to: New Drug Applications (NDAs), study protocols, clinical study reports, investigator brochures, regulatory submissions, etc.
• Ensures accuracy, clarity and consistency of scientific content in all documents
• Collaborates with clinical researchers, biostatisticians and other stakeholders to gather and interpret data
• Contributes to research protocol and amendment development
• Supports regulatory submissions by preparing high-quality documents meeting regulatory requirements
• Stays current with industry standards/advancements in medical writing and regulatory requirements
• Provides medical writing guidance and supports cross-functional teams (i.e., clinical development, regulatory affairs, biostatistics, external vendors, etc.)

• Oversees, and works independently on, medical writing projects ensuring timely and accurate completion

Requirements

QUALIFICATION REQUIRED:

• Bachelors degree and minimum 10 years experience in medical writing in the pharmaceutical, biotechnology or related healthcare industry

• Masters or PhD in a scientific discipline (i.e., Life Sciences, Medicine, Pharmacy) PREFERRED
• Previous experience working with NDAs and other regulatory submissions

• Knowledge of regulatory requirements and guidelines for clinical trials
• Proficiency in medical writing software and templates (i.e., EndNote, Starting Point, etc.)

• Experience with data management and quality assurance processes

We are a HYBRID work environment requiring candidates to be able to come into office periodically or as needed. This position also requires limited domestic and international travel, on occasion.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid