Staff Clinical Science/medical Writing

4 days ago

Gurgaon, India Saraca Solutions Full time

**Who We Want**
- **Effective communicators.** People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
- **Accuracy-oriented team leaders.** Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
- **Data translators.** Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
- **Dedicated achievers. **People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

**What You Will Do**

As the Staff Medical Writer, you will support the Clinical Evidence team within the Clinical Affairs function. You will maintain responsibility for managing several Clinical Science/ Medical Writing deliverables. You will work with confidential company data and will interface with cross-functional internal and external stakeholders.
- Author clinical trial protocols, interim and final clinical study reports, including Clinical Evaluation Plans and reports, PMCF Plans and reports, summary of effectiveness and safety integrated safety/performance data summaries
- Perform formal literature searches, and succinctly summarize scientific content for assigned projects.
- Contribute to Pre-Submissions, Design and Value dossiers for matrix submissions
- Contribute to Publications in drafting abstracts, podium presentations and manuscripts
- Collaborate with other staff to resolve complex or unclear situations.
- Propose and participate in departmental continuous improvement initiatives.
- Assist in training staff.

**What You Need**
- A minimum of a Bachelor’s Degree required; emphasis in health/science-related field preferred.
- A Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) preferred.
- Strong scientific and medical writing skills required.
- Experience in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required.
- Experience in IDE / Class III products/ clinical trials preferred.
- Previous knowledge of the Vascular space preferred.
- Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task and problem solve.
- Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.
- Knowledgeable in AMWA code of ethics and appropriate guidelines required.
- Adept at word and power point processing, document management and change control.
- Excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology preferred.

**Experience**
- A minimum of 6 years of combined experience in clinical research, medical writing, clinical science or 3 years of combined experience in clinical research, medical writing, clinical science with a Master’s Degree or 2 years of combined experience in clinical research, medical writing, clinical science with a PhD required.

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