Sr. Director Medical Communications/Publications
Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body; develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large. To support our continued growth Tris is expanding the team at our Monmouth Junction, NJ facility and has an opening for an experienced Sr Director/Director, Medical Communications and Publications.
The Senior Director/Director, Medical Communications and Publications leads the scientific medical communication and publication functions to accurately and compliantly disseminate clinical data and meet the needs of patients and health care professionals (HCPs) and the organization. The incumbent leads and has oversight for the implementation of strategic publication and scientific communication plans in alignment with the overall Medical Affairs and Clinical Development strategies. She/he also develops and implements quality control measures as needed to ensure accuracy of data communicated.
• Accountable for the development of publication strategy, development of publication plans and implementation of publication-related projects demonstrating strong knowledge of therapeutic landscape
• Leads the Data Dissemination team meetings, organizes publication planning participants and implements feedback into strategy to ensure publication plans are effective and efficient
• Collaborates closely with the VP, Head of Clinical Medical Affairs, and other key R&D and Commercial functional leads to develop and/or support key medical communications strategic documents, including but not limited to: Medical strategic plan, Scientific platform, Tactical Plans (Data Dissemination Plan (aka Publications Plan), Medical Information Plan (aka Call Center strategy), Medical Congress Plan, etc. )
• Oversees and directs the content generation process for Medical Affairs written deliverables including, but not limited to: manuscripts, abstracts, posters and platform presentations of peer-reviewed medical data, Standard Response Documents, Custom Responses, and Verbal Response Scripts, etc. as needed within Medical or Clinical Affairs either as primary writer/author or through use of external medical writing resources
• Review all deliverables to ensure publications and presentations meet quality control standards and are balanced in content; Oversight of medical, legal, regulatory and IP review of publications to ensure company alignment and compliance
• Lead efforts to build awareness of publications and scientific communications to support internal strategic business decision-making
• Oversees and directs Medical Information Call Center (vendor selection/vetting/quality assurance and process management, etc.); Liaises with Product Quality, Commercial, and Pharmacovigilance, and other departments, as needed, to ensure optimal management of process and of vendors
• Oversees and directs Medical Review Committee process (MRC) for medical materials, including, but not limited to: Standard Operating procedures (SOPs), medical document and material repository, and authoring/approval tools (and provide backup as needed as MRC Medical Reviewer)
• Leads and directs medical information congress presence including, but not limited to: booth staffing, scheduling and resource development, liaising with Commercial team on overall Congress planning and execution, etc.; Identifies and creates resources for medical congress booth
• Liaise with external authors and internal contributors and manage publication specific meetings with contributors, including any medical writers and/or agencies as needed; Develops relationship with societies and congressed to support congress submissions
• Oversight of literature searches/alert distribution based on scientific understanding of company focus and priorities on selected therapeutic topics/areas; Monitor and implement industry best practices (i.e. ICMJE, GPP, PhRMA code) as they relate to publicationsRequirements
Bachelors degree in medical or scientific discipline (MA, PhD, PharmD, etc. PREFERRED) AND minimum 5 years experience in medical communications and/or publications in the pharmaceutical, biotechnology or related industry REQUIRED. Job title and level determination will be commensurate with experience.
• Working familiarity with all regulatory and industry standards related to medical communications REQUIRED
• Excellent understanding of the pharmaceutical corporate environment and strong working knowledge of Commercial Operations functions, including Marketing and Sales strategies REQUIRED
• Hands on experience with promotional and non-promotional materials review REQUIRED
• Successful track record of management of outsourced medical information vendors REQUIRED
• Documented history of manuscript publication (either as acknowledged writer or listed author) REQUIRED
• Medical Information management experience REQUIRED
• Ability to influence without direct authority REQUIRED
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.