Sr Medical Writer - Early Development

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A day in the Life:

Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
Represents the department at project launch meetings, review meetings, and project team meetings.

Keys to Success:

Education

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred

Experience

Previous regulatory medical writing experience required (comparable to 5+ years).
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills, Abilities

Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Strong project management skills
Excellent interpersonal skills including problem solving
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
Great judgment and decision-making skills
Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Set alert for similar jobsSr Medical Writer - Early Development role in Mumbai, India

Company

Thermo Fisher Scientific

Job Posted

a year ago

Job Type

Full-time

WorkMode

Remote

Experience Level

3-7 years

Locations

Mumbai, Maharashtra, India

Qualification

Bachelor

Applicants

Be an early applicant

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