Trinity Life Sciences is a trusted strategic commercialization partner, providing evidence-based solutions for the life sciences. With 25 years of experience, Trinity is committed to solving clients’ most challenging problems through exceptional levels of service, powerful tools, and data-driven insights. Trinity’s range of products and solutions serve pharmaceutical, biotechnology, and medical technology companies.
Trinity’s Evidence Strategy team supports clients in strategically planning, executing, and deploying evidence to inform an asset’s value strategy in the marketplace. Leveraging best-in-class, scientifically-driven, publication-quality primary and secondary research methods, we help our clients demonstrate the holistic value of their assets across the product lifecycle. We proactively guide the development of publication-grade evidence to cover a broad range of communication needs—including driving disease-state awareness, increasing product awareness, and identifying keys to successful adoption and utilization. We partner with our clients to identify and overcome potential roadblocks, strategically plan for market access challenges, and create evidence to support their strategic pricing goals.
The Medical Writer collaborates with members of our cross-functional Evidence, Value, Access, and Pricing (EVAP) team to identify the value messages pertinent to the client’s need and prepare high-quality materials communicating these value messages across a range of formats within agreed-upon timelines. The Medical Writer should be familiar with scientific methods including literature reviews, randomized controlled trials, real-world evidence studies, etc. and have the ability to create documents appropriate for payer discussions (e.g., global/AMCP value dossiers).
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
- Prepare, edit, and finalize documents for publication in scientific forums (including manuscripts, conference posters/presentations) and, as needed, additional client materials (such as global/AMCP dossiers, objection handlers, scientific information exchange presentations, final study reports, etc.)
- Participate in scientific communication planning, including development of recommendations of journals and conferences that effectively target key stakeholders for the therapeutic area and align with the desired cadence of communication
- Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in tables, figures, and listings, and other information sources
- Schedule and conduct document-related meetings, including the preparation of pre-meeting agenda and offline reviews for project team members
- Collaborate with health economics and outcomes research teams, including experts in primary and secondary research, key opinion leaders, clinicians, and biostatisticians, to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Complete documents according to agreed-upon timelines and follow up with the study team as needed to meet internal and external timeline commitments
- Ensure compliance with standard operating procedures and regulatory guidance
- Ensure that appropriate documented quality control checks are performed on medical writing deliverables
- Suggest or identify changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required.
Education/Experience: The ideal candidate will offer:
- At minimum bachelor’s degree or equivalent in medical-related field or life science. Post-graduate degree (MPH or PhD) preferred.
- Bachelor’s degree +8 years, Master’s Degree +3 years, Doctoral Degree +1 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred
- An understanding of the drug development process
- Understanding of Health Economic & Outcomes Research methodologies and study design, including ability to transfer study results into peer-reviewed publications (abstracts/posters, manuscripts, and presentation materials)
- Experience conducting literature reviews and synthesis
- Broad experience conducting the medical writing responsibilities associated with multiple studies at various stages
- Experience in interacting with cross functional study team members
Knowledge, Skills and Abilities:
- Must have knowledge of medical writing standards including ICMJE guidelines; demonstrated ability to interpret and apply these guidelines to document writing
- Must have knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases
- Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
- Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
- Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
- Read, write, and speak fluent English; excellent verbal and written communication skills
Work Environment: This is a high growth, fast paced organization. The ability to be productive and successful in an intense work environment is critical. Qualified candidates have the ability to work remotely and working time will be driven by client deliverables and deadlines.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.