For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.ProPharma is seeking an experienced
Senior Medical Writer II
to join our dynamic team in India. In this role, you will be responsible for authoring high-quality medical writing deliverables that demonstrate precision, clarity, and efficiency. As a key contributor, you will provide expert medical writing support to ProPharma’s global clients, ensuring that all documents meet the highest scientific and regulatory standards. This position offers the opportunity to collaborate with cross-functional teams, contribute to impactful healthcare solutions, and grow within a leading provider of regulatory, clinical, and medical information services worldwide.
Essential Functions
- With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents).
- Supervises, trains, and mentors less experienced medical writers, as necessary.
- Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
- Strives to complete medical writing deliverables on time and within budget.
- With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.
- Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
- Coordinates QC reviews of documents and maintains audit trails of changes as applicable.
- Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
- If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).
- Performs peer review of documents written by other medical writers, as required.
- Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
- Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
- Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
- Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
- Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.
- Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).
Necessary Skills & Requirements
- Bachelor’s degree or higher, in a medical or scientific discipline.
- Minimum of 6 years’ experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics within a CRO, pharmaceutical, or biotechnology environment.
- Proven expertise in authoring and editing a wide range of medical writing deliverables across clinical, safety, regulatory, and device/diagnostics documents.
- Strong knowledge of clinical research principles, phases, and therapeutic areas, with the ability to interpret and present complex clinical data.
- Advanced understanding of global regulatory guidelines, submission requirements, and processes (e.g., ICH E3/E6(R2), EU MDR/IVDR, FDA, EMA), with proficiency in applying SOPs, client standards, and templates.
- Exceptional project management, communication, and time-management skills, with high attention to detail and quality.
- Experience mentoring junior writers and building collaborative relationships with clients and cross-functional teams.
- Proactive, resourceful, and adaptable, with the ability to work independently while seeking support when needed.
Requirements
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
