This position is offered fully Home based (Remote)
As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.
Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.
If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

DESIRED SKILLS AND QUALIFICATIONS:

• Master’s or doctorate degree in biological sciences or equivalent
• Project management certification or degree preferred
• 10 years of experience with at least 3 years’ experience in a management role. Experience within the pharmaceutical/CRO industry preferred
• Wide breadth of experience in multiple therapeutic areas and phases of clinical studies and observational research
• Advanced word processing skills (Microsoft Word) and advanced Adobe Pro skills
• Familiarity with different document management systems
• Knowledge of medical terminology and understanding of the clinical trial process and observational research
• Ability to interpret data and strong analytical skills and communicate to cross-functional teams
• Strong leadership and organizational skills
• Attention to detail/high degree of accuracy
• Strong communication and interpersonal skillsUBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.#LI-AP1#LI-Remote

• Prepare documents and provide leadership and management of Medical Writing group, including medical writers who prepare:
• Abstracts, posters, manuscripts, plain language summaries for publication
• RWE and observational research documents
• Phase 1 through IV and post marketing regulatory documents including
• Phase I-IV and post-marketing regulatory documents: clinical protocols and study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry and observational study protocols and reports, risk evaluation and mitigation strategy (REMS) assessment reports, knowledge, attitude, and behavior surveys (KABS) reports
• Prepare slide decks and reports as needed, including KOM slide decks
• Engage with KOLs, clients, and authors
• Ensure peer review and QC of documents for publishing according to standard operating procedures (SOPs).
• Participate in UBC and client project teams for project planning and development of timelines; Develop and manage project and deliverable timelines
• Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Epidemiology, Quality Assurance, and Project Management on Medical Writing projects.
• Lead preparation and review of departmental standard operating procedures (SOPs) to improve efficiencies and quality of processes.
• Participate in requests for information (RFIs) and requests for proposals (RFPs) for business development opportunities.