Staff Clinical Science/Medical Writing Job Vacancy in Saraca Solutions Gurgaon, Haryana – Latest Jobs in Gurgaon, Haryana – updated today

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Company Name : Saraca Solutions
Location : Gurgaon, Haryana
Position : Staff Clinical Science/Medical Writing

Job Description : 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
Provide clinical science subject matter expertise and consultation to Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.
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 +91-XXXXXXXXXX) 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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