Job Description

Full-time Medical & Regulatory Writer



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 a full-time regulatory writer. Read on to find out more



Why this is a great opportunity


• Use our state-of-the-art CRO lab
• Collaborate with our network of hospitals
• Get exposure to a panel of experts
• Work on niche therapeutic areas

What you will do


• Regulatory writing 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