Regulatory Medical Writer
Regulatory Medical Writer
Syner-G
Job description
Are you looking to develop your career in medical writing and pharmaceutical regulatory writing? Syner-G is looking for a Consultant I, Medical Writing in Bengaluru, Karnataka.
Company Description
Syner-G is a biopharmaceutical consultancy and project management firm that guides enterprises through medication development, regulatory approval, and commercialisation. They work with clients to accelerate scientific innovation and assist in bringing treatments to patients. It focuses on collaboration, professional growth, quality delivery and an enabling workplace culture that allows employees to be part of projects that have meaningful healthcare outcomes.
Job Summary
The Scientific Writer post is responsible for writing and management of regulatory documents for pharmaceutical and biotechnology businesses. This is a remote role and will include compilation of clinical trial reports, study protocols, submission materials and sophisticated regulatory paperwork. The successful publication writer will be accountable for timelines, quality documentation, client relations and cross-functional team collaboration. The position demands industry experience, scientific writing abilities and knowledge of regulatory filings and standards.
Key Responsibilities
Prepare and write regulatory documentation including Clinical trial Reports (CSRs), clinical trial procedures and materials for regulatory submissions.
Oversee the preparation of complicated regulatory documentation such as Module 2 summaries, briefing documents, Orphan Drug, Fast Track and Breakthrough Therapy designation applications.
Ensure documentation meets submission requirements, customer expectations and agreed delivery timelines by carrying out quality checks.
Monitor progress and update timetables for given projects, and communicate changes in project needs to clients.
Expect project delays or difficulties ahead of time and keep clear timetables to avoid delays in the completion.
Attend clients, discuss and respond to queries to ensure effective working relationships.
Review materials for scientific accuracy and consistency and for conformity with applicable regulatory standards.
Collaborate with cross-functional teams to ensure quality and reliability of regulatory paperwork.
Assist in the creation of regulatory strategies for early stage companies and smaller clients.
Help clients and coworkers using document management tools, internal protocols, and standard operating procedures (SOPs).
Work on a variety of documents under the guidance of senior professionals and get exposure to new processes and industry best practices.
Educational Qualification
Advanced degree in a life science or health science discipline (Preferred).
Suitable qualifications are MSc, PharmD, PhD or MD.
Regulatory Affairs Certification (RAC) provides an added advantage.
Candidates should have a minimum of 3 years of industry experience.
Experience in regulatory submissions and global regulatory requirements is desired.
Skills Required
Good skills in medical writing and regulatory writing.
Ability to comprehend scientific data and present it accurately in regulatory documents.
Experience in pharmaceutical and biopharmaceutical development, clinical trials and regulatory submissions.
Knowledge of Microsoft Word, Excel, Powerpoint, Microsoft Teams and Microsoft Project.
Experience with Veeva Vault or other regulatory documentation management solutions.
Knowledge of regulatory guidance and submissions internationally.
Excellent writing and verbal communication skills with the ability to clearly articulate challenging scientific concepts.
Strong co-ordination, scheduling and time management skills.
Capable of prioritising work and adjusting project plans as necessary.
Analytical aptitude and critical thinking to ensure that scientific statements are evidence-based.
Excellent attention to detail in reviewing and maintaining document uniformity.
Cross-cultural communication is a part of an empathetic and collaborative attitude to client engagement.
Salary Structure
The average expected compensation for a Regulatory Medical Writer is ₹6-7 Lakhs per year.
Career Development
The position as a scientific writer provides an opportunity for further knowledge in medical information writing, scientific literature assessment, regulatory writing and pharmaceutical communications. Working with medical teams can also help to build subject-matter knowledge and lay the foundation for future advancement into senior medical writing and medical information roles.
How to Apply
Open our job portal. Search for Regulatory Medical Writer listing.
Review the full job information and check the eligibility conditions.
Fill out the application form. Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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