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Basic purpose of the job

Independently writes and manages clinical documents, such as clinical trial reports, Investigation Brochures, Protocols and briefing documents, in both local and global cross-functional project- and study teams, as well as local clinical regulatory documents for submission to the Japanese Health Authority (HA) and other documents related to HA interaction. Provide critical input to the analysis and interpretation of clinical data in the assigned writing projects.

Accountabilities

Responsible for the preparation of clinical documents on study- and project-level required for advancing clinical development programs. This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the study and project teams.

Requires proactive and continuous cross-functional coordination to ensure timely and successful document finalisation.

Related performance indicators

Quality and timeliness of clinical documents. Compliance of documents with international guidelines and corporate SOPs. Successful and efficient interaction with teams.

Ensure quality of clinical documents assigned to external providers by appropriate oversight and training. Contribute to appropriate budget planning and cost control.

Related performance indicators

Quality of outsourced clinical documents and compliance with relevant SOPs. Stay within timeline and budget.

Develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio. Share knowledge with other medical writers (e.g. by giving presentations in team or group meetings).

Related performance indicators

Extent and quality of contribution. Achievement of development objectives.

Advance MW standards by contributing to process improvement initiatives and working groups with cross-functional impact.

Related performance indicators

Extent and quality of contribution. Readiness to participate in working groups. Successful and efficient interaction with working group members.

Regulatory and / or Organisational Requirements

Apply regulatory guidelines related to clinical documents (ICH, GCP) on local and regional level. Comply with all applicable SOPs and company policies.

Job Complexity

The job involves working in global, cross-functional study and project teams, and dealing with complex scientific issues in clinical development programs. The job requires the ability to critically assess, interpret, and describe clinical data and to resolve conflicting reviewer’s feedback. Additional complexity is introduced by external providers, and working in different regulatory contexts (e.g. US, EU, Asia). The job requires handling numerous complex tasks simultaneously.

Interfaces

External interfaces include: Regulatory Authorities; Principal and Coordinating Investigators; CROs and other external providers.

High number of internal interfaces, usually on global level and mostly for liaising, partnering, and negotiating deliverables: Clinical Operations, including Global MW leadership, Human Pharmacology Center and Early Clinical Operations; TAs Medicine (Head of Medicine, Clinical Project Leads); Statistics; Data Management; Programming; Translational Medicine and Clinical Pharmacology; Medical Affairs; Regulatory Affairs; Global Pharmacovigilance; Quality Assurance/Compliance; Transparency/Disclosure; Therapeutic Area Committees; functions within Research and Development, including Chemistry, Manufacturing, and Controls, Pharmacology, Drug Metabolism and Pharmacokinetics, and Nonclinical Drug Safety.

Job Expertise

Sound knowledge in scientific and/or regulatory writing, including clinical trial reports of all clinical phases and other clinical documents; understanding of international writing standards and conventions. Good knowledge in assigned therapeutic area and its clinical standards. Sound knowledge in clinical documents standards and regulatory requirements. Understanding of the business impact of timelines for clinical documents.

Job Impact

Ensuring quality and timeliness of clinical documents that reflect company-strategic goals, thereby contributing to the advancement of clinical programs including fast and successful registrations of Boehringer Ingelheim development compounds. Applying strong leadership in the matrix in regard to clinical document creation and finalisation (study-level and project-level). Overseeing the work of external providers.

Minimum Education/Degree Requirements

Minimum Bachelor degree in Pharmacy, Medicine or Life Science.

Advanced degree in Pharmacy, Medicine or Life Science preferred.

Required Capabilities (Skills, Experience, Competencies)

Skills and Competencies:

Ability to independently and effectively communicate complex clinical information in writing for the target audiences; scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data; understanding of the clinical development process and relevant global and local regulatory guidelines.

Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers, ability to manage parallel tasks and variable workload, strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, ability to manage conflicting reviewer’s comments, and presentation skills; diplomacy; cultural sensitivity; ability to contribute to process improvements; proficiency in word processing and presentation software; excellent written and verbal English and Japanese skills.

Experience:

Previous experience in scientific and/or regulatory medical writing is preferred.

Recruiter : Suzuki

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.