Senior Scientific Writer
Senior Scientific Writer
Parexel
Job description
Interested in clinical trial transparency and regulatory writing? Explore Parexel’s Senior Scientific Writer role, leading disclosure submissions, anonymisation, regulatory guidance, and patient-facing trial information for global clients across markets, remotely.
Company Description
Parexel is a clinical research organisation and clinical development partner serving the life sciences industry. It works with biopharmaceutical companies, medical-device manufacturers, and academic institutions to design and conduct clinical trials. Its teams combine clinical, regulatory, and therapeutic expertise to support research quality, regulatory compliance, and patient-focused drug development worldwide.
Job Summary
The Senior Scientific Writer role includes protocol registrations, results posts, plain-language summaries, lay protocol synopses, anonymisation within packages, and redaction explanations. It also provides regulatory counsel, manages difficult projects, assures compliance across jurisdictions, improves processes and mentors junior authors inside the clinical development context.
Key Responsibilities
Independently lead the preparation, review and submission of clinical trial transparency submissions, including protocol registrations, results postings, Plain Language Summaries (PLS), Lay Protocol Synopses (LPS), redaction and anonymisation packages, anonymisation reports and Confidential Commercial Information (CCI) justification tables.
Write and review complex clinical and regulatory papers like Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, Safety Reports.
Provide clients and internal teams with strategic and regulatory advice on clinical trial disclosure obligations.
Interpret regulatory requirements and advise on proper courses of action for complex disclosure issues.
Lead client engagements, autonomously manage complicated disclosure projects from inception to delivery, and aid in client decision-making on regulatory issues.
Ensure that submissions fulfil quality standards and regulatory requirements in numerous jurisdictions.
Participate in process improvement, best practice development, and mentoring of junior medical writers on disclosure requirements and regulatory compliance.
Educational Qualification
Bachelor’s degree in Life Sciences, Health Sciences or a relevant discipline and equivalent work experience.
Proven professional experience in medical writing, with a focus on clinical trial disclosure and transparency.
In-depth knowledge of worldwide clinical trial disclosure and transparency regulations, including: EudraCT, CTIS/EU-CTR, EMA Guideline 0070, Health Canada standards.
Extensive experience in protocol registration, results reporting, registry maintenance and disclosure compliance strategies.
Skills Required
Comprehensive knowledge of global clinical trial transparency requirements, protocol registration, outcomes reporting and registry maintenance.
Ability to author and review clinical protocols, CSRs, Investigator Brochures, informed consent forms and other regulatory documentation.
Experienced in identifying personal data and private commercial information for redaction in accordance with applicable data protection legislation.
Ability to interpret complex clinical & regulatory material into concise, patient-friendly documents.
Ability to manage complicated disclosure projects, advise clients, organise stakeholders, mentor younger authors, and provide timely, quality deliverables.
Salary Structure
The average salary of a Senior Scientific Writer in India between ₹15.5 Lakhs to ₹17.2 Lakhs per year.
Career Development
Medical Writers have prospects for technical and management development at Parexel. From Senior Scientific Writer post, you can progress to Subject Matter Expert or people-management positions, establishing competence in clinical trial transparency, regulatory submissions, client consulting and team leadership.
How to Apply
Go to our job portal and search for Senior Scientific Writer role.
Open the listing and check the job responsibilities, eligibility and experience criteria.
Fill in the needed information and submit your latest resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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