Medical Services Executive – R&D
Macleods Pharmaceuticals Ltd.
Location: Andheri, Mumbai (R&D Centre)
About Macleods Pharmaceuticals Ltd.:
Macleods Pharmaceuticals is a leading global pharmaceutical company committed to innovation. Our robust R&D team develops high-quality, affordable medicines, improving patient lives worldwide. Join us and contribute to a legacy of excellence in pharmaceutical research and development.
Job Summary:
We are seeking a diligent and experienced Medical Services Executive to join our Research & Development team at our Andheri, Mumbai facility. This pivotal role involves comprehensive medical documentation, literature review, and regulatory support, critical for pharmaceutical product development and submission. The ideal candidate will possess a strong understanding of medical affairs and regulatory requirements within the pharmaceutical industry.
Key Responsibilities:
- Prepare detailed Module 2.4 Non-Clinical Overviews and Non-Clinical Study Matrices.
- Develop Module 2.5 Clinical Overviews and Clinical Study Matrices per regulatory guidelines.
- Draft and finalize critical patient and product information: Pack Inserts (PI), Patient Information Leaflets (PIL), and Summary of Product Characteristics (SPC).
- Manage the approval process for pharmaceutical product artworks.
- Conduct extensive scientific literature searches encompassing non-clinical, clinical, and formulation aspects.
- Create comprehensive Product Monographs.
- Formulate various rationales (e.g., for Fixed-Dose Combinations (FDC), efficacy, dosing strategies).
- Oversee and monitor in-house Bioavailability and Bioequivalence (BABE) studies.
Qualifications & Experience:
- Education: Master of Pharmacy (M.Pharm) or M.Pharm (Pharmacology) is essential.
- Experience: A minimum of 2 to 3 years of hands-on experience in a Medical Services, Medical Affairs, or Medical Writing role within the pharmaceutical industry.
- Note: This is an experienced-level position; applications from freshers will not be considered.
Skills & Attributes:
- Proficiency in regulatory documentation and CTD (Common Technical Document) modules.
- Exceptional written and verbal communication skills, with an emphasis on scientific accuracy.
- Proven ability to conduct systematic literature reviews and synthesize complex data.
- Strong analytical skills and meticulous attention to detail.
- Ability to work effectively both independently and collaboratively within a fast-paced R&D environment.
Work Mode:
This is a full-time, on-site position based at our R&D facility in Andheri, Mumbai. No hybrid or remote work options are available for this role.
How to Apply:
Qualified and interested candidates are invited to submit their updated resume to adityab@macleodspharma.com. Please ensure that “Medical Services” is clearly stated in the subject line of your email for proper routing.
