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Senior Medical Writer-RWE

Trigent Software Private Limitedbangalore, India

11 hours ago

Job description

Position : Senior Medical Writer-RWE

Location : Bangalore

Job Type : Full-time employment

Department : Medical Writing-MCAPL

Job description and responsibilities :

Author, edit, and review a wide spectrum of documents including clinical protocols, study reports, investigator brochures (IBs), regulatory submissions, manuscripts, abstracts, and presentation materials .
Design and lead real-world data and epidemiological studies (protocols, data collection, analysis, and interpretation) to assess disease trends, health outcomes, and risk factors; support regulatory submissions, and deliver study reports, publications, and presentations.
Convert detailed scientific and clinical findings into content tailored for diverse stakeholders such as regulators, sponsors, patients, and healthcare professionals.
Conduct comprehensive literature research to support evidence-based writing and maintain the integrity of scientific messaging.
Work collaboratively with clinical, regulatory, medical, marketing, and technical teams to maintain scientific accuracy and message consistency across deliverables.
Participate in cross-departmental meetings to gather insights, align on expectations, and support project timelines.
Incorporate feedback from internal reviewers, external stakeholders, and quality review processes to refine documents.
Oversee document version control and workflow management in accordance with project tracking tools.
Keep abreast of therapeutic area advances, evolving regulatory frameworks, and best practices in medical writing.
Provide technical mentorship, manage project timelines and budgets, and collaborate with cross-functional teams, sponsors, regulatory bodies, academia, and external data partners while ensuring compliance with evolving public health and regulatory standards.
Clinical Data Management : Lead eCRF design, data collection, entry, validation, query management, database testing (including UAT), and ensure timely delivery of clean, reliable datasets through interim reviews and database lock.
Quality and Compliance : Prepare DMPs / DVPs, implement edit checks and reconciliation procedures, coordinate with cross-functional teams and vendors, and maintain compliance with GCP, ICH, and 21 CFR Part 11 while driving process improvements.

Qualifications :

Master's degree in Life Sciences, Epidemiology, Public Health, Biostatistics; Bachelor's degree in Medicine, Pharmacy or a related field (Ph.D., PharmD or MD preferred).

3-5 years of professional experience in medical / scientific writing, applied epidemiology, and / or public health research within CRO, pharma, or academic settings.

Strong understanding of medical and scientific concepts with proven ability to translate complex information into clear, concise content for diverse audiences.

Excellent scientific writing, editing, and verbal communication skills with a high level of attention to detail.

Proficiency in Microsoft Office Suite and reference management tools (e.g., EndNote, Zotero).

Knowledge about statistical software (e.g., SAS, R, Python) and data visualization tools is an advantage.

Ability to manage multiple projects, meet deadlines, and work both independently and collaboratively across teams.

Preffered attributes :

Experience writing in specific therapeutic areas (oncology, neurology, rare diseases).

Publication record in peer-reviewed journals or experience supporting manuscripts and congress materials.

Experience in managing clinical research would be beneficial.

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Senior Medical • bangalore, India