Medical Writing

5+ years

Not Disclosed

Bangalore

10 Aug. 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Senior Medical Writer

Company: Quanticate

Location: India

About Us: Quanticate is a leading global clinical research organization partnering with pharmaceutical, biotechnology, and medical device companies to support their regulatory and scientific communication needs. We are seeking a talented and experienced Senior Medical Writer to join our Medical Writing team in India.

Position Overview: The Senior Medical Writer will be responsible for developing high-quality clinical study documents, including protocols, clinical study reports, and regulatory submission documents. They will collaborate with cross-functional teams to ensure adherence to guidelines and timelines. The ideal candidate will have a deep understanding of clinical research and regulatory requirements, with excellent writing, editing, and proofreading skills to translate complex scientific data into clear, concise, and accurate documents.

Key Responsibilities:

Produce well-written, high-quality, and timely medical writing documents such as clinical study reports, protocols and amendments, Investigator's Brochure (IB) and IB updates.
Review medical writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed.
Provide editorial support and proof-reading for documents produced by other departments or clients.
Oversee medical writing projects and cross-functional projects using project management tools and processes.
Manage the document review process, ensuring conflicting and ambiguous comments are clarified and addressed.
Assist Principal Medical Writers and above with managing department budgets and financials.
Contribute to business development by updating CVs, preparing and reviewing client proposals, and presenting at client and bid defense meetings.
Line manage assigned personnel, actively contributing to their development and providing guidance and mentorship to less experienced medical writers.
Conduct literature reviews and provide input on the development of scientific communication and messaging.
Manage timelines and deliver documents within established deadlines.

Qualifications:

Master's degree or higher in a life science or related field.
Minimum 5 years of experience as a medical writer in the pharmaceutical, biotechnology, or CRO industry.
Strong knowledge of clinical research, regulatory requirements, and industry guidelines (ICH-GCP).
Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific information effectively.
Experience in writing clinical study documents, such as protocols, clinical study reports, and regulatory submission documents.
Detail-oriented with excellent organizational and time management skills.
Ability to work independently and collaboratively in a team environment.

Benefits:

Competitive salary (open to discussion based on experience).
Flexible working hours.
Generous leave policies (annual leave, sick leave, casual leave, and bank holidays).
Medical insurance for self and immediate family.
Gratuity.
Accidental coverage.
Various learning and development opportunities, including mentoring, coaching, e-learning, and job shadowing.

Application Process: Quanticate will never ask for payments as part of the recruitment or hiring process. All legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit. We do not ask or require candidates to deposit any money or complete any paid courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at Quanticate Careers.

Join Quanticate and be a part of a dynamic team committed to supporting the regulatory and scientific communication needs of leading global companies.

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