Opening in Medical Writing Position @ GVK
Job Description
By using scientific expertise, to develop high-quality, regulatory and publication-ready scientific documents (Investigators brochure, Protocols, Clinical study reports, Informed consent forms, Clinical CTD modules, clinical trial registries, manuscripts, risk management plans, PSURs, posters, abstracts, presentations, etc.) based on non-clinical and clinical studies by organizing, critically examining, and interpreting scientific and statistical data;
Document review and quality check of all documents prepared by medical writers from team
Establish and maintain good working relations with medical writing team, and clients;
To ensure customer expectations are met; manage quality, timelines and high scientific standards for all documents produced by team;
To prepare training plans for team members based on developmental needs identified via feedback on an on-going project;
Work with international pharmaceutical clients and liaise with internal and external stakeholders, including authors and key opinion leaders on critical therapeutic area issues;
Develop and maintain necessary templates, formats, and styles to ensure that documents generated meet industry, regulatory, internal, and client requirements;
Research, write, edit and proof copy to the highest standard (scientific and grammatical) for a full range of regulatory, medical education and communications materials;
Basic knowledge of biostatistics.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Documentation/Medical Writing
Role: Documentation/Medical Writing
Keyskills: Manuscript Writing, CSR, Clinical Study Reports, Protocol Writing, CTD, Medical Writing, Regulatory Writing
Desired Profile
- Expertise in MS Word, Power Point, MS Excel
- Clear, concise, scientific style of writing, with a high level of attention to detail and superior English-language skills with strong communication skills
- Ability to multi-task and work under tight timelines
- Ability to multi-task and work in a matrixed organization
- Ability to work both independently and as part of a team
- Excellent time management skills
CSR, Manuscript and protocol writing previous experience must
Education:UG -B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine
PG - M.Pharma - Pharmacy, M.S/M.D - Any Specialization, M.Sc - Any Specialization
Doctorate - Ph.D - Advertising/Mass Communication, Bio-Chemistry/Bio-Technology, Biomedical, Biotechnology, Immunology, Medicine, Microbiology, Pharmacy, Rheumatology
Company Profile
GVK is today among India's leading transnational business conglomerates. GVK's areas of activity range from power and hospitality to biotechnology, manufacturing, finance, petrochemicals and infrastructure development. The diverse GVK enterprises are united by a common vision. GVK is dedicated to making positive contributions for a better future.
Click here to apply
Job Description
By using scientific expertise, to develop high-quality, regulatory and publication-ready scientific documents (Investigators brochure, Protocols, Clinical study reports, Informed consent forms, Clinical CTD modules, clinical trial registries, manuscripts, risk management plans, PSURs, posters, abstracts, presentations, etc.) based on non-clinical and clinical studies by organizing, critically examining, and interpreting scientific and statistical data;
Document review and quality check of all documents prepared by medical writers from team
Establish and maintain good working relations with medical writing team, and clients;
To ensure customer expectations are met; manage quality, timelines and high scientific standards for all documents produced by team;
To prepare training plans for team members based on developmental needs identified via feedback on an on-going project;
Work with international pharmaceutical clients and liaise with internal and external stakeholders, including authors and key opinion leaders on critical therapeutic area issues;
Develop and maintain necessary templates, formats, and styles to ensure that documents generated meet industry, regulatory, internal, and client requirements;
Research, write, edit and proof copy to the highest standard (scientific and grammatical) for a full range of regulatory, medical education and communications materials;
Basic knowledge of biostatistics.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Documentation/Medical Writing
Role: Documentation/Medical Writing
Keyskills: Manuscript Writing, CSR, Clinical Study Reports, Protocol Writing, CTD, Medical Writing, Regulatory Writing
Desired Profile
- Expertise in MS Word, Power Point, MS Excel
- Clear, concise, scientific style of writing, with a high level of attention to detail and superior English-language skills with strong communication skills
- Ability to multi-task and work under tight timelines
- Ability to multi-task and work in a matrixed organization
- Ability to work both independently and as part of a team
- Excellent time management skills
CSR, Manuscript and protocol writing previous experience must
Education:UG -B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine
PG - M.Pharma - Pharmacy, M.S/M.D - Any Specialization, M.Sc - Any Specialization
Doctorate - Ph.D - Advertising/Mass Communication, Bio-Chemistry/Bio-Technology, Biomedical, Biotechnology, Immunology, Medicine, Microbiology, Pharmacy, Rheumatology
Company Profile
GVK is today among India's leading transnational business conglomerates. GVK's areas of activity range from power and hospitality to biotechnology, manufacturing, finance, petrochemicals and infrastructure development. The diverse GVK enterprises are united by a common vision. GVK is dedicated to making positive contributions for a better future.
Click here to apply
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