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Senior Specialist/Expert Medical Writer

5+ years
Not Disclosed
10 Dec. 31, 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, 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

Work Your Magic with Us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – and so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our diverse mix of people, customers, patients, and the planet. That’s why we are always looking for curious minds who see themselves imagining the unimaginable with us.


Title: Senior Specialist/Expert Medical Writer
Location: Bangalore


About the Role:

As a Senior Specialist/Expert Medical Writer, you will support the medical writing efforts for marketed products and lifecycle management at both global and regional/local levels. You will be responsible for the preparation of clinical and regulatory documents, including protocols, clinical study reports, and investigator brochures.

Key Responsibilities:

  • Independently prepare clinical and regulatory documents such as Protocols, Clinical Study Reports, or Investigator Brochures.
  • Support submissions for market approval or line extensions under minimal supervision.
  • Contribute proactively to the development and implementation of medical writing best practices and process improvements.
  • Oversee and coordinate external writers, ensuring adherence to business objectives, company standards, and content clarity.
  • Ensure all documents are produced according to agreed timelines, regulatory requirements, and company standards.
  • Participate in meetings related to medical writing, quality control, and compliance activities.

Who You Are:

  • A graduate or postgraduate degree in BPharm/MPharm, PhD, BDS (Dental), BSC/MSC, or equivalent with comprehensive medical writing knowledge.
  • 4 to 9 years of regulatory medical writing experience.
  • Excellent written and spoken English, including medical terminology, and familiarity with the AMA style guide.
  • Knowledge of clinical and regulatory documents.

We Are an Equal Opportunity Employer:

We value workforce diversity and believe that everyone should bring their best self to work. Equality and inclusion are at the forefront of all our activities. We are committed to a policy of non-discrimination in employment on any basis, including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.


What We Offer:

We celebrate diversity because it drives excellence and innovation. Join us and build a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.


Apply now and become a part of our diverse team!


US Equal Employment Opportunities:
The Company is an Equal Employment Opportunity employer. No employee or applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable law. This policy applies to all employment decisions.


North America Disclosure:
If you reside in California, Colorado, Hawaii, Maryland, New York, Washington, or Washington, DC, you are eligible to receive additional information about compensation and benefits upon request. Please contact 855-444-5678, 8:00 am – 5:30 pm ET, Monday through Friday for assistance.


Notice on Fraudulent Job Offers:
Be cautious of third parties pretending to represent our company offering unauthorized job opportunities. Please refer to our official website for more information if you suspect a fraudulent source.


What We Offer:

In addition to financial rewards, we offer a range of attractive benefits:

  • Saving & Financial: Our 401(k) plan includes company-matching contributions and additional discretionary contributions each year. We also provide tax-advantaged accounts for healthcare, commuting, and life insurance.

  • Health & Wellness: Comprehensive medical, dental, and vision coverage, including virtual care through Telehealth and free behavioral health counseling.

  • Voluntary Benefits: Additional protection from healthcare costs and discounts on auto, home, pet insurance, and low-interest personal loans.

  • Work/Life Support: Generous paid time off, back-up daycare services, education assistance, and more.


Our Recruiting Process:

  1. You Apply: Submit your application for the role that matches your qualifications.
  2. We Screen: We review your application and determine if you’re a good fit.
  3. We Assess: You will be interviewed by phone, video, or face-to-face.
  4. Mutual Agreement: If you’re the right match, we hope you’ll join us!
  5. Work Your Magic: Our onboarding process ensures you a smooth start.