Purpose
Develop medical writing content within the pharmaceutical industry, collaborate in a matrixed, team environment, and apply internal standards, regulatory guidelines, and publishing guidelines to successfully deliver clinical documents.
You will be responsible for
Writing and coordinating basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial investigative brochures.
Contributing to and coordinating low‑to‑medium complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, investigative brochure updates, summary documents, and regulatory responses under supervision.
Performing document QC, completing lists of abbreviations or references, conducting literature searches, and other basic tasks with supervision as needed.
Leading cross‑functional document planning and review meetings and participating in process working groups.
Managing timelines and scheduling for assigned projects and interacting with cross‑functional colleagues to champion medical writing processes and best practices.
Establishing document timelines and strategies in accordance with internal processes, with mentorship from functional management and clinical teams.
Guiding or training cross‑functional team members on processes and best practices.
Leading early‑or late‑stage compound writing teams with supervision, as required.
Learing and adhering to SOPs, templates, the Medical Writing Style Guide, and industry regulatory guidelines.
Meeting with managers and mentors, attending departmental and cross‑functional meetings, and completing time reporting, training, and metrics database updates.
Maintaining and applying knowledge of industry, company, and regulatory guidelines and mentoring junior staff on document planning, processes, content, or providing peer review.
Qualifications / Requirements
University or college degree in a scientific discipline (advanced degree, such as Master’s, PhD, or MD, preferred).
Minimum of 2 years of relevant pharmaceutical or scientific experience.
Minimum of 2 to 4+ years of regulatory medical writing experience, depending on task complexity and supervision required.
Strong oral and written communication skills, attention to detail, and time‑management abilities.
Ability to work effectively in a team environment and grow learning agility.
Demonstrated ability to build solid, productive relationships with cross‑functional team members.
Experience interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content.
Emerging leadership skills in project and process management, including influencing, negotiating, assertiveness, and initiative taking.
Knowledge of regulatory guidance documents such as ICH requirements.
Required Skills
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Preferred Skills
Business behavior, business writing, clinical research, and regulations
Clinical trials operations, coaching, collaboration, copy editing
Data gathering and analysis, data savvy, document management, industry analysis
Medical affairs, medical communications, problem solving, process oriented
Proofreading, quality standards, research ethics
Location: Allschwil, Basel-Country, Switzerland
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