Quality Engineering Program Manager, Post Market
Medtronic
Senior Medical Writer, CSR, IB, Protocol Drafting
Syneos Health
full-time
Posted on:
Origin: • 🇮🇳 India
Visit company websiteJob Level
Senior
About the role
- Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manage medical writing activities for individual studies and coordinate across departments
- Prepare clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PSURs, clinical development plans, IND/IDS/NDAs and eCTD submissions, integrated summaries, manuscripts, abstracts, posters, and presentations
- Adhere to regulatory standards including ICH E3, company SOPs, client standards, templates, and style guides
- Coordinate quality and editorial reviews and act as peer reviewer
- Review SAPs and TFL specifications and provide feedback on statistical outputs
- Interact with clients and cross‑functional teams (data management, biostatistics, regulatory, medical affairs)
- Perform online clinical literature searches and comply with copyright requirements
- Identify and resolve issues, provide technical support, training, and consultation
- Mentor and lead less experienced medical writers and develop subject matter expertise
- Work within budget specifications for assigned projects
Requirements
- Bachelor's degree in a relevant discipline (graduate degree preferred)
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices
- Experience writing clinical study protocols, amendments, CSRs, patient narratives, IBs, informed consents, regulatory submissions, and manuscripts
- Extensive knowledge of English grammar; strong familiarity with AMA Manual of Style
- Strong presentation, proofreading, collaborative, and interpersonal skills
- Strong project and time management skills
- Strong proficiency in MS Office
- Strong understanding of medical terminology, clinical research principles, and ability to interpret and present clinical data
