Comw-0 Principal Medical Writer

Merck & Co.

10 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

Principal Medical Writer – Join Our Global Healthcare Team

Location: Various Locations
Posted Date: January 2025

Work Your Magic with Us!

Are you ready to push boundaries, discover more, and transform lives? We know you have big plans – and we have exciting opportunities for you! At our global company, we are passionate about innovating in science and technology across Healthcare, Life Science, and Electronics. Together, we dream big, working toward improving the lives of people, customers, patients, and the planet. We are always seeking curious minds that want to imagine the unimaginable with us.

United as One for Patients, our mission in Healthcare is to help create, improve, and prolong lives. We develop cutting-edge medicines, devices, and technologies in therapeutic areas such as Oncology, Neurology, and Fertility. Our diverse teams collaborate across six continents, with passion and relentless curiosity, to support patients at every stage of life. By joining our Healthcare team, you become part of a diverse, inclusive, and flexible work culture offering excellent personal development and career growth globally.

Who You Are:

Graduate or post-graduate degree in BPharm/MPharm, PhD, BDS (Dental), BSc/MSc, or equivalent experience, with comprehensive medical writing knowledge of principles and concepts.
Over 10 years of experience in the Pharma industry, including 5 to 8 years in Regulatory medical writing (including postmarketing studies).
Proficiency in written and spoken English (including medical terminology) and familiarity with the AMA style guide.

Responsibilities:

As a Principal Medical Writer, you will be a pivotal leader for medical writing efforts on marketed products and lifecycle management, both globally and regionally. You will:

Independently prepare or oversee the preparation of regulatory documents such as Clinical Study Reports, Protocols, Investigator Brochures, and Clinical Summary documents.
Support submissions for market approval and line extensions with minimal supervision.
Coordinate external writers to ensure document quality, consistency, and adherence to business objectives and timelines.
Represent the department as a subject-matter expert during clinical study team meetings and document reviews.
Ensure all documents meet regulatory requirements, follow standard operating procedures (SOPs), and adhere to company standards.
Contribute to the development and implementation of medical writing best practices and process improvements.

What We Offer:

We value curiosity and diverse perspectives and offer a range of benefits, including:

Financial Benefits: 401(k) with generous company contributions, tax-advantaged healthcare accounts, and life insurance.
Health & Wellness: Comprehensive medical, dental, and vision coverage, virtual care, behavioral health support, wellness incentives, and personalized benefits assistance.
Voluntary Benefits: Discounts on auto, home, and pet insurance, as well as low-interest personal loans.
Work/Life Balance: Generous paid time off, back-up daycare services, and education assistance programs.

Our Recruiting Process:

Apply: Submit your application for a role that matches your qualifications.
Screen: We’ll review your application and, if you’re a good fit, move you to the next step.
Assess: Interview via phone, video, or face-to-face.
Mutual Agreement: If we’re a perfect match, we’ll offer you a role.
Work Your Magic: Join us and begin your journey with smooth onboarding.

Didn’t Find the Right Job?

No problem! Stay connected with us through our Talent Zone and explore future career opportunities. We’d love to hear from you!

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Comw-0 Principal Medical Writer

Job Description

Who You Are:

Responsibilities:

What We Offer:

Our Recruiting Process:

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