Medical Writer III – Line Management Experience Required
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇳 India
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
- Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
- Support in all pharmacovigilance operations associated with medical writing
- Continuous self-education in all aspects associated with medical writing
- Managing a team of junior medical writers
Requirements
- Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
- Pharmacy, Medicine or advanced Life Science degree
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to effectively train and mentor Associate Medical Writers
- Advanced knowledge of English
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingpharmacovigilancePBRER writingDSUR writingRMP writingquality system documentationregulatory document authoringeditingreviewingattention to detail
Soft skills
team managementtrainingmentoringprioritizationself-education
Certifications
Pharmacy degreeMedicine degreeLife Science degree