Medical Writer

2 days ago

Haryana, India Pratham Search Full time

Currently we required Medical writer for leading medical device company

location - Nuh, Mewat, Sohna
- Skilled in writing, reviewing and editing scientific medical write-ups including medical

studies, drug trials, study reports, white papers, summaries and regulatory documents, or

marketing medical writing.
- Developing scientific content that is compliant with ICH, GLPs, and GCPs guidelines.
- Ability to communicate scientific or medical information in a clear and concise manner

literature search.
- Experience in medical device regulatory document preparation including Clinical

Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up

Plan/Report, Periodic Safety Update Report (PSUR) for Medical devices, Summary of

Safety and Clinical Performance (SSCP) Report etc. would be preferable.
- Familiarity with the principles of clinical research
- Ability to analyze, interpret and present clinical data and other complex information
- A basic understanding of the analyses used in clinical trials so that the incumbent is

comfortable with statistics.
- Contribute to document quality control (reviewing data accuracy, formatting and

appropriateness of language, and compliance to industry guidelines)
- Ensuring the accuracy of all information, data and referencing for the

publications/documents produced
- Being proactive in tracking projects and determining timelines
- Working on a diverse projects at the same time

**Qualifications**:
A Master’s degree or PhD in relevant life science field (Pharmacology, biological sciences,

Prior experience as a scientific/ medical writer in an agency/ CRO/ academic/ industry

environment preferable

Familiarity with industry principles that are relevant to the organization, such as drug safety,

regulatory guidelines or pharmacology.

Knowledge in Medical Device regulatory process and regulations.

Experience in conducting focused literature searches on PubMed, MedLine or other similar

medical literature database

Basic understanding of Medical Writing, including familiarity with writing styles such as

American Medical Association

Understanding of global regulatory agencies and regulatory processes concerning medical devices

A strong work ethic and a solution-focused attitude combined with intellectual curiosity and

creativity

A passion for medical communications and education

The ability to work effectively in teams in a fast-paced, dynamic and creative enviorment.

Pay: ₹50,000.00 - ₹60,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Day shift
- Morning shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

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