Pharma Tips

Manager-Medical Writing

By: Pharma Jobs | Views: 1760 | Date: 09-May-2011

One of our reputed clients, providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research is looking for Manager-Medical Writing to create a variety of response documents (standard and custom medical letters, and expedited abstracts) for global use by client and its affiliates when they respond to questions from health care providers


Client of PhiRMS Pvt Ltd , hiring for A Global CRO

Summary
 

Experience:

7 - 12 Years

Location:

Hyderabad / Secunderabad, Pune

Compensation:

Rupees 8,00,000 - 16,00,000

Education:

UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization,Post Graduation Not Required

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Documentation/Medical Writing

Functional Area:

Healthcare, Medical, R&D

Posted Date:

09 May

Desired Candidate Profile

 A bachelor's degree in a health- or scientific-related related field, M.S. M.A. MPH, PharmD, or Ph.D is preferred.

2 - 3 years relevant management experience, preferably in a CRO environment

5+ years experience in regulatory medical writing within the CRO, pharmaceutical or biotechnology industries

Neurology experience preferred

Excellent verbal and written communication skills, interpersonal skills, team skills, and presentation skills.

Understanding of the drug development process required.

Familiarity with regulatory clinical trial reporting guidelines, particularly ICH E3, required.

Strong management and independent work skills.

Medical writing experience in the preparation of Phase I through Phase IV clinical study reports and in the summarization and reporting of efficacy and safety data for regulatory filings (NDA/CTD).

Experience in the analysis, summarization, and interpretation of scientific data and an ability to communicate clinical data succinctly, clearly, and accurately in writing.
Job Description

Ensures timely completion and delivery of work product to clients.

Ensures quality of work product delivered to clients.

Documents quality findings in written monthly summary reports to Global Director of Medical Writing and Scientific Communications.

Develops and maintains departmental Standard Operating Procedures (SOPS) for medical writing and report processing services.

Works with other relevant line functions to prepare documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.

Provides technical review of documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.

Actively supports ongoing business development efforts related to medical writing and report processing services.

Participates in presentations to clients for general capabilities as well as specific project proposals as needed.

Participates in professional meetings to enhance and maintain industry recognition of medical writing and report processing capabilities.

Assesses departmental resource needs, collaborating with Human Resources on hiring, retention, and termination activities.

Ensures departmental adherence to agreed upon standards, templates and formats and document management procedures, including training of writers.

Mentor medical writers and other members of the project team who contribute to report preparation.

 
Keywords: Medical Writing, Regulatory, Scientific, Safety

Company Profile
One of our reputed clients, providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research is looking for Manager-Medical Writing to create a variety of response documents (standard and custom medical letters, and expedited abstracts) for global use by client and its affiliates when they respond to questions from health care providers

Contact Details
Company Name:

Client of PhiRMS Pvt Ltd

Website:

Not Mentioned

Executive Name:

Suvidha Mahajan

Address:

Not Mentioned

Email Address:

jobs@phirms.com

Telephone:

011-45767513,9560170077

Reference ID:

Manager-Medical Writing

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