Are you a highly motivated and detail-oriented Medical Writer looking for a new challenge? Do you have a passion for clinical trials and medical writing? If so, we have exciting news for you! BP Clinical is hiring a Medical Writer with 1-2 years of experience in clinical trial management.
About the Job
As a Medical Writer at BP Clinical, you will be responsible for end-to-end clinical trial management, including design, documentation, regulatory submissions, and reporting. You will work closely with Principal Investigators, CROs, SMOs, ECs, and RAs to ensure compliance with regulatory requirements and company policies.
Key Responsibilities
Clinical trial management: design, documentation (Protocol, ICF, CRF, IB, CSR), regulatory submissions, and reporting
Medical writing and safety reporting, including SAE/SUSAR narratives, MedWatch forms, and MedDRA coding for US-FDA
Coordination with PI, CRO, SMO, EC, and RA
TMF maintenance and recruitment management
Investigational Product handling: labelling, randomisation, dispatch, recall, and reconciliation
Site management: initiation, monitoring, audits, and close-out
CTRI registration and implementation of SOPs/WIs for process standardisation
Requirements
M.Pharm degree with 1-2 years of experience in clinical trial management
Strong knowledge of clinical trial regulations and guidelines (ICH-GCP, US-FDA, CDSCO)
Excellent writing and communication skills
Ability to work independently and as part of a team
Strong attention to detail and organisational skills
What BP Clinical Offers
Competitive salary and benefits package
Opportunity to work on a wide range of clinical trials and projects
Collaborative and dynamic work environment
Professional development and growth opportunities
State-of-the-art facilities and equipment
Why Choose a Career in Medical Writing?
Medical writing is a critical function in the pharmaceutical and biotechnology industries, where professionals create and review clinical trial documents, reports, and regulatory submissions. As a medical writer, you’ll have the opportunity to work on a wide range of projects, from clinical trials to regulatory submissions. With the increasing demand for clinical trials and regulatory submissions, this field offers a promising career path with opportunities for growth and development.
Skills and Qualifications
Strong knowledge of clinical trial regulations and guidelines (ICH-GCP, US-FDA, CDSCO)
Excellent writing and communication skills
Ability to work independently and as part of a team
Strong attention to detail and organisational skills
Familiarity with clinical trial management systems and tools
Career Growth and Development
At BP Clinical, we’re committed to providing our employees with opportunities for career growth and development. As a Medical Writer, you’ll have the opportunity to work on a wide range of projects and develop your skills in areas such as:
Clinical trial management and documentation
Regulatory submissions and reporting
Medical writing and safety reporting
Clinical trial operations and management
Leadership and management
Conclusion
If you’re a highly motivated and detail-oriented Medical Writer looking for a new challenge, we encourage you to apply for this exciting opportunity at BP Clinical. With a competitive salary and benefits package, collaborative and dynamic work environment, and opportunities for professional growth and development, this is a career path you won’t want to miss.
📬 How to Apply
Send your CV to hr@bpclinical.com
with the subject line:
➡️ Application for Medical Writer – BP Clinical
Frequently Asked Questions
Q: What is the primary responsibility of a Medical Writer?
A: The primary responsibility of a Medical Writer is to create and review clinical trial documents, reports, and regulatory submissions.
Q: What skills are required for a Medical Writer?
A: A Medical Writer should have strong knowledge of clinical trial regulations and guidelines, excellent writing and communication skills, and the ability to work independently and as part of a team.
Q: What kind of career growth and development opportunities are available?
A: We offer professional development and growth opportunities, including training and certification programs, leadership development, and opportunities to work on high-profile projects. SEO Keywords: Medical Writer, Clinical Trials, Regulatory Submissions, Medical Writing, Safety Reporting, Clinical Trial Management, BP Clinical, Career Growth and Development, Clinical Trial Regulations, ICH-GCP, US-FDA,