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Freelance Medical & Regulatory Writer

Pepgra
Ambattur, Chennai, Tamil Nadu

Apply Now

Job details

Freelance

Qualifications

Doctoral degree
English
Diagnostic evaluation
Master's degree
Bachelor's degree

Full job description

Pepgra scientific editing and publication division serves clients across the globe. We offer editing, publication support, medical writing, translation, transcription, and researcher training services, to help individuals achieve their scientific communication goals. Pepgra employs a global team of highly skilled scientific editors, writers and peer reviewers who are experts in various scientific academic fields.

We’re currently looking for Freelance medical & regulatory writer. Read on to find out more.

Why this is a great opportunity

Flexibility to determine your schedule and work hours.
Potential to earn plenty (based on regular availability) based on editing jobs online.
Further monetary benefits of up to 20% and assurance of regular work for editors who consistently deliver high-quality work.
Learning opportunities and regular feedback on your freelance editing assignments.

What you will do

Medical & regulatory writer in compliance with EU and US standards and protocols.
Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables.
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).
Provide strategic guidance on regulatory requirements to new product development teams and sustaining teams.
Write, edit clinical study protocols, clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
Write, edit preclinical summary documents.
Manage document reviews.
Support technical/clinical/regulatory writing for global regulatory submissions in electronic format.
Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines. Ensure compliance with company or client SOPs and style guidelines.
Write and maintain Standard Operating Procedures and Style Manuals for internal process and external process.
Prepare manuscripts, review articles, abstracts, posters and presentations in support of company programs according to International Committee of Medical Journal Editors (ICMJE) standards and requirements.
Quality audit all documents prior to publishing.

What you need

A PhD/Masters/Bachelor’s degree or expertise in one or more specialized subject areas in healthcare, medicine and surgery, and Cancer Research.
Excellent English editing skill and attention to detail.
AMWA/EMWA certification will be a great value add.

Subject areas include but limited to the following:

Medicine:
Anesthesiology and pain medicine
Complementary and alternative medicine
Dentistry
ENT (Otolaryngology)
Internal medicine
Immunology
Genetics
Ophthalmology
Optometry
Other – Medicine, Radiology, Respiratory care, head and neck surgery, and veterinary sciences
Allied Healthcare:
Disaster medicine
Diabetes research
Emergency and critical care
Endocrinology, Epidemiology
Forensic medicine
Geriatric medicine
Hematology
Infectious diseases
Nursing and hospital medicine
Nutrition and dietetics
Occupational health and therapy
Public health
Allergies – Clinical
Cancer Research:
Chemo radiotherapy
Cancer research – Molecular, Radiotherapy planning
Organ systems, physical medicine, and rehabilitation:
Anatomy
Cardiology
Chiropractics
Dermatology
Gastroenterology and Hepatology
Biomedical devices - Clinical applications
Nephrology
Obstetrics and Gynaecology
Plastic surgery
Orthopedics
Paediatrics
perinatology, and child health
Physical medicine and rehabilitation
Plastic and reconstructive surgery
Reproductive medicine
Rheumatology
Sexual health
Sports medicine
Surgery - Cardiac and Cardiothoracic
Transplantation – Surgery, Urology, Stroke – Cardiology

Apply Now

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Why this is a great opportunity

What you will do

What you need

Subject areas include but limited to the following:

Medicine:

Allied Healthcare:

Cancer Research:

Organ systems, physical medicine, and rehabilitation:

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