Clinical Scientist (India)
Location
Pune | India
Job description
The Clinical Scientist is responsible for medical writing activities at Innovaderm. The individual will author or contribute to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications.
This role will be perfect for you if :
- You are a strong medical writer with demonstrated ability to produce high-quality scientific documents to support clinical research.
- You enjoy learning continuously and keeping yourself informed.
- Having an impact within a growing company with momentum motivates you.
RESPONSIBILITIES
- Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;
- Collaborates to clinical development of Phase 1/First-in-Man studies, Proof of Concept (POC) trials, Phase 2b – 3 studies, and Phase 4/registry trials.
- Contributes to study design and writes/reviews clinical study protocols/amendments;
- Reviews informed consent/assent forms, study reference manuals, statistical analysis plans, and mock shells of statistical tables/figures/listings;
- Reviews, analyzes, and interprets study data based upon scientific expertise and industry standard practices;
- Writes/reviews narratives and clinical study reports;
- Prepares scientific abstracts, posters, and manuscripts;
- Performs on-line literature searches;
- Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;
- May perform quality control review of documents prepared by other team members;
- Participates in process improvement efforts of the department.
Our company:
The work environment
At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Clinical Scientist, you will be eligible for the following perks:
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
About Innovaderm
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in India.
REQUIREMENTS
IDEAL PROFILE
Education
- MSc in life sciences; PhD is an asset;
Experience
- Experience in writing clinical / regulatory documents such as study protocols and clinical study reports;
- Experience analyzing and reporting on study data
Knowledge and skills
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
- Good knowledge of drug development process;
- Advanced English writing skills; strong English communication skills; French is an asset;
- Strong proficiency of Word;
- Ability to handle varied and multiple tasks, organize own work, and prioritize workload;
- Has excellent attention to detail;
- Client-focused attitude;
- Quick learner, good adaptability, and versatile.
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