Senior Medical Regulatory Writer

Job title : Senior Medical Regulatory Writer

• Location : Hyderabad

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally .

Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.

At the core of this mission is our 100+ loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.

Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet.

Find out more about our mission to bring health in your hands at www.opella.com.

About the job:

The senior medical writer will write, edit and provide deliverables (CSR, CO, SCE, SCS, SCP, SBP,

PBRER, ACO, RMP, ID Cards, clinical evaluation report, briefing packages, HAQs, Immunogenicity

reports) as per agreed timelines and quality across CHC therapeutic areas. To ensure the delivery of high quality, scientifically accurate, and regulatory-compliant documents that support global regulatory submissions.

Main responsibilities:

Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.

• Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
• Develops and maintains TA expertise.
• Reviews content created by peers’ writers.
• Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.

People:

• Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.
• Interact effectively with stakeholders in medical and pharmacovigilance departments.
• Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.

Performance:

• Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical
• evaluation report, briefing packages, medical section of CTA, managing Product Alerts, posting of
• trial information such as study protocol and amendments, study results, redacted documents, lay
• summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality.

Process:

• Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
• Assist the assigned medical team in conducting comprehensive medical regulatory writing needs analysis.
• Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
• Work with selected vendors within the region to deliver the required deliverables as per the defined process.
• Design an overall plan of action basis end-customers feedback & improve course content and delivery.
• Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.
• Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Opella Policy or Quality Documents evolution.
• 9)Ensure timely and accurate registration of clinical trials on public registries (e.g., ClinicalTrials.gov, EudraCT, CTR).
• 10) Oversee the disclosure of trial results in accordance with global regulatory requirements and company policies.
• 11) Serve as a subject matter expert (SME) on trial transparency and disclosure requirements.

Stakeholders:

• Work closely with Clinical/Medical/Clinical trial management teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
• Proactively liaise with the Clinical/Medical / Clinical trial management Pharmacovigilance /Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables

About you:

Education:

• Medical or Pharmacy Degree. Scientific/health related degree (PhD, Phar.D.) is acceptable if supported by good experience.

Experience:

• At least 7-8 years of relevant work experience in Pharmaceutical Industry and/or in Consumer Healthcare is a real asset
• Previous experience in global or regional role, desirable
• Experience in technical writing for healthcare authority submissions and/or scientific publications, desirable

Why us ?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers