Medical Writer Jobs in India - For a Client of Teamlease Digital

FEATURED JOB

Medical Writer

For a Client of Teamlease Digital

4.5 Years

400000 Yearly

Expired

Posted: 04 Nov 22

Job Description

Role Description: The Medical Writer authors scientific documents including but not limited

to protocol, clinical study reports, inform consent forms, clinical modules (2.5 and 2.7

summaries), lay summaries, CSR narratives, Investigator’s brochure etc.

Principal Accountabilities

Write and review the above mentioned documents: study protocol, clinical study reports,

inform consent forms, clinical modules (2.5 and 2.7 summaries), lay summaries, CSR

narratives, Investigator’s brochure, Briefing books and/ or anonymization activities (EMA

Policy 0070)

 If required and as applicable, manage some of the sub-contracted medical writing

activities with offshore team

 Liaise with sponsor project managers, data managers, statisticians to deliver high

quality results as appropriate. Coordinates for document authoring, review and

approval (end-to-end activities).

 Demonstrate knowledge of assigned therapeutic areas and assigned products.

 Have basic knowledge of key statistical concept.

 Ability to compare and interpret data across different MAA, and its logical

representation.

 Research, develop and write content that is scientifically accurate, evidence-based,

grammatically accurate, referenced using appropriate sources, and consistent with

quality standards.

 Be able to clearly communicate medical scientific concepts in a condensed way.

 Demonstrate the flexibility/adaptability necessary to function on different therapeutic

teams as needed.

 Interpret and apply clinical data in medical communication deliverables

 Responsible for consistency, checks documents for data errors and uniformity with

source documents.

General Requirements

 Well-versed with International Conference on Harmonization (ICH) Good Clinical

Practice (GCP) guidelines and regulatory requirements for scientific documents

 Strong English writing capabilities

 Solid medical/ scientific knowledge in any of Oncology, Inflammatory, Rare

Diseases, neuroscience and cardiovascular therapeutic areas

 Autonomy

 Excellent oral English communication skills

Qualifications, Skills and Experience

Master degree, preferably in life sciences, chemistry or engineering (biotechnology/bio-

informatics)

 A postgraduate qualification in life sciences discipline is desirable although not

essential

 Experience of developing positive, credible and lasting relationships with senior level

managers, and clinical teams

 Demonstrable analytical, interpretative and problem-solving skills, the ability to

simplify all research procedural communications to the variety of research roles is

essential

 Scientific writers require deep understanding of regulations governing research

conduction, as well as of the respective governing bodies (FDA or EMA) for content

development.

 Strong capability in managing projects and juggling priorities so that deadlines are

met while retaining consistently high-quality outcomes

 4+ years medical report writing experience

 Excellent conversational and business English (written and oral)

More information about this Medical Writer Job

Please go through the below FAQs to get all answers related to the given Medical Writer job

What are the job requirements to apply for this Medical Writer job position?
- Ans: A candidate must have a minimum of 3+ year experience as an Medical Writer

What is the qualification for this job?
- Ans: The candidate can be a Graduate from any of the following: MSc
What are the salary requirements for this job?
- Ans: The salary range is between 400000 Yearly. The Salary will depend on the interview. This Medical Writer is a Full Time in Ahmedabad, Faridabad, Gurgaon.
What is the hiring Process of this job?
- Ans: The hiring process all depends on the company. Normally for an entry level, hiring the candidate has to go for Aptitude, GD (If they look for communication),Technical test and face to face interviews.
This Medical Writer is a work from home job?
- Ans: No ,its not a Work from Home Job.
How many job vacancies are opening for the Medical Writer position?
- Ans: There are immediate 10 job openings for Medical Writer in our Organisation.