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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