Lead Scientist: Medical Writing

From 5 to 8 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

  • Responsible for preparation and review of clinical trial documents (Investigators Brochure, Protocol, ICD) in accordance with documented guidelines, SOPs within stipulated timelines.
  • Effectively accomplish the medical writing activities & build expertise across the different document types assigned.
  • Interpretation of clinical data and other related information in a most acceptable quality document (Interim Report or Clinical Study Report)
  • Co-ordinate and maintain an effective relationship with Scientific Strategy and Medical writing team and Clinical Operations study team to provide high quality Clinical trial documents.
  • Provide the scientific feedback on the essential documents related to conduct of clinical trial.
  • Write scientific abstracts, publication, related to clinical studies.
  • Provide scientific inputs on Healthcare website, health magazine etc.
  • Work closely with multidisciplinary group of experts to translate the study data and results into presentations, reports, regulatory documents, scientific journal manuscripts and abstracts for publication.
  • Should conduct comprehensive literature searches to enhance background understanding and evaluate and analyse the information.

Desired Candidate Profile

  • Medical writing skills, including grammatical, editorial, and proofreading skills.
  • Good knowledge of English grammar with a familiarity of writing clinical trial documents
  • Familiarity with the principles of clinical research
  • Knowledge of global, regional, national and other document development guidelines
  • Comfort of searching the scientific information available on open resources.
  • Ability to communicate scientific or medical information in a clear and concise manner
  • Must be aware of current industry practices and regulatory requirements.
  • Must keep abreast of current literature, emerging science, technological developments and medical trends.

Role Requirements:

  • M Pharm/ MSc/ Pharm D/ BDS/ PhD (Pharmacology) or degree in alternative medicine (BAMS/ BHMS) with 5 years experience in Medical writing (related to Clinical Trials Document & Publications).
  • Hands on experience in literature search, targeted literature review, preparation of scientific document, disease or drug related literature based on data available from publications, clinical trials.
  • Experience in preparation of scientific abstracts, publication would be preferred
  • Desirable to have thorough knowledge of clinical trial concepts including ICH-GCP, CFR and applicable regulatory guidelines (DCGI, USFDA, MHRA)
Key Skills
Skills highlighted with ‘‘ are preferred keyskills

Education

PG:Any Postgraduate

Company Profile

The Himalaya Drug Company

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
Company Info
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View Contact Details+

Contact Company:The Himalaya Drug Company

Address:THE HIMALAYA DRUG COMPANY,,THE HIMALAYA DRUG COMPA, NY,TUMKUR ROAD,MAKALI, BANGALORE, Karnataka, India

Salary:

Not Disclosed by Recruiter

Role Category:

Healthcare & Life Sciences - Other

Role:

Healthcare & Life Sciences - Other

Employment Type:

Full Time, Permanent