Medical Regulatory Writer

2+ years

Not Disclosed

Hyderabad

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Regulatory Writer
Company: Sanofi Business Operations
Location: India (specific location not provided)

About Sanofi:

Sanofi Business Operations is a resource organization within Sanofi, centralized in India to support multiple functions such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital. This team is focused on providing tactical support to Medical, HEVA, and Commercial organizations globally. At Sanofi, we pursue progress and innovation, aiming to make extraordinary discoveries that improve the lives of patients.

Main Responsibilities:

As a Medical Regulatory Writer, you will be responsible for writing, editing, and managing various medical documents in compliance with regulatory guidelines. You will work closely with global and local teams to produce high-quality documents and ensure timely delivery.

Essential Duties and Responsibilities:

Medical Document Writing and Editing:
- Write and/or edit safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER), clinical overviews, Disease and Product ID Cards, product alerts, and trial transparency documents.
- Ensure all deliverables are in compliance with internal and external standards and guidelines.
Collaboration:
- Work under the guidance of mentoring medical writers to plan data analysis and presentation.
- Collaborate with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and Regulatory teams.
- Maintain effective relationships with end stakeholders in the medical scientific community.
People Management and Stakeholder Engagement:
- Interact with stakeholders across Medical, Clinical, Pharmacovigilance, and Regulatory departments.
- Assist other medical regulatory writers in developing their knowledge and sharing expertise.
- Support in managing relationships with vendors and external partners.
Performance and Process Management:
- Deliver medical documents (e.g., PBRER, ACO, Product Alerts, clinical trial data) on time and with high quality.
- Ensure audit and inspection-readiness of all medical documents.
- Track postings and archive materials in relevant systems.
- Stay updated on Sanofi’s evolving policies and quality documents.
Regulatory Compliance and Quality:
- Maintain an in-depth understanding of medical regulatory requirements for countries supported.
- Track and review trial information for websites such as CT.gov, EUCTR, EUDRACT, and others.

Qualifications:

Experience:

Minimum of 2 years of experience in regulatory writing for the pharmaceutical/healthcare industry.

Soft Skills:

Strong stakeholder management and communication skills.
Ability to work independently and as part of a team.
Vendor management experience.

Technical Skills:

Excellent technical editing and writing skills.
Proficiency in data retrieval, interpretation of scientific data, and medical literature screening.
Knowledge of ICH and GCP/GVP guidelines.
Ability to summarize and edit scientific information for specific audiences.

Education:

Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Master's, or Bachelor's in Science, PharmD).
Medical degree (MBBS, BDS, BAMS, BHMS, MD) is also acceptable.

Languages:

Excellent command of the English language (reading, writing, and speaking).

Why Sanofi?

At Sanofi, we believe progress happens through people. We offer opportunities for growth and development, with a culture of innovation and inclusion. Whether you're pursuing career advancement or exploring new challenges, Sanofi supports your professional and personal growth every step of the way.

We are an equal-opportunity employer and value diversity in our workforce. We welcome candidates from all backgrounds to contribute to our mission of making extraordinary changes happen in healthcare.

Apply Now:

If you're ready to pursue progress and make a difference in healthcare, join Sanofi's mission to discover extraordinary solutions.

Visit our careers page to apply.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Richmond Hill | Mississauga | Uxbridge | North York |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Netanya | Tel Aviv | Kfar Saba | Be'Er Sheva |

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Medical Regulatory Writer

Job Description

About Sanofi:

Main Responsibilities:

Qualifications:

Why Sanofi?

Apply Now:

Latest Jobs

Medical Coder

Hospital Pharmacist

Principal Statistical Programmer

Senior Principal Biostatistician

Associate Director - Pks Drug Disposition, Hyd

Tco Physician

Director - Pks Gh Ta Lead

Medical Director Ii

Clinical Operations Specialist

Analyst, Global Stability