Senior Specialist/Expert Medical Writer

5+ years

Not Disclosed

Bangalore

10 Jan. 17, 2025

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, CPC Certified, 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

Senior Specialist/Expert Medical Writer – Join Our Dynamic Team in Bangalore

Location: Bangalore
Posted Date: January 2025

Work Your Magic with Us!

Are you ready to explore, innovate, and break barriers in the world of healthcare and life sciences? We know you have big plans – and we do too! Our colleagues worldwide are passionate about harnessing science and technology to improve lives. Together, we dream big, working toward impactful solutions for people, patients, customers, and the planet. We're always on the lookout for curious minds ready to imagine the unimaginable.

About the Role:

As a Senior Specialist/Expert Medical Writer, you will play a critical role in supporting Medical Writing efforts for marketed products and lifecycle management on a global, regional, and local scale. You will:

Independently prepare clinical and regulatory documents such as Protocols, Clinical Study Reports, and Investigator Brochures.
Support market approval/line extension submissions with minimal supervision.
Contribute to the development and implementation of Medical Writing best practices and process improvements.
Oversee and coordinate the work of external writers, ensuring content quality, clarity, and adherence to company standards.
Ensure all documents are delivered on time and meet the requirements of both regulatory authorities and internal SOPs.
Participate in meetings related to key Medical Writing, QC, and compliance activities.

Who You Are:

Graduate or post-graduate degree in BPharm/MPharm, PhD, BDS (Dental), BSc/MSc, or an equivalent qualification, with a strong background in medical writing.
4-9 years of experience in Regulatory medical writing.
Proficient in written and spoken English, with familiarity with AMA style guide.
Solid knowledge of clinical and regulatory documentation.

What We Offer:

We’re committed to nurturing talent, embracing diversity, and fostering innovation. Here’s what you can expect when you join our team:

Financial Security: Our 401(k) plan includes generous company matching contributions.
Health & Wellness: Comprehensive medical, dental, and vision coverage, including virtual care and free behavioral health support.
Voluntary Benefits: Discounts on insurance and other services, plus financial protection for unexpected healthcare costs.
Work-Life Balance: Generous paid time off, daycare services, and education assistance.

Our Recruiting Process:

Apply: Complete your application online for roles that align with your qualifications.
Screen: Our team will review your application and assess your fit for the role.
Assess: You’ll be interviewed via phone, video, or in person.
Mutual Agreement: If we’re a match, we’ll extend an offer!
Onboarding: Start your journey with us, with a seamless onboarding experience.

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Senior Specialist/Expert Medical Writer

Job Description

About the Role:

Who You Are:

What We Offer:

Our Recruiting Process:

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