• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Medical Information Writer

    Sanofi
    2-5 years
    Not Disclosed
    Hyderabad
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Information Writer

    Main Responsibilities:

    • Scientific Documentation:

      • Conduct literature searches, reviews, and data extraction from scientific literature.
      • Generate evidence-based, accurate, and fair-balanced summaries for the creation and maintenance of scientific response documents for products in designated therapeutic areas.
      • Adapt global scientific response documents for assigned countries.
      • Develop responses to escalated inquiries for assigned countries.
      • Contribute to US NDA Annual Reports and US compendia reviews.

    • Content Development:

      • Maintain Therapeutic Area expertise.
      • Review content created by peer writers.
      • Collaborate with Global Medical Information teams to execute content plans.

    People Management:

    • Stakeholder Relations:
      • Maintain effective relationships with end stakeholders (Medical scientific community) within the allocated Global business unit and product.
      • Interact with stakeholders in medical and pharmacovigilance departments.
      • Assist other medical information writers in developing knowledge and sharing expertise.

    Performance:

    • Deliverables:
      • Provide scientific response documents, US NDA Annual Reports, and US compendia reviews as per agreed timelines and quality standards.

    Process:

    • Expertise and Implementation:
      • Act as an expert in medical information writing and stay updated on regulatory requirements for supported countries.
      • Assist in conducting comprehensive medical writing needs analyses.
      • Implement content plans and associated activities for assigned countries.
      • Work with selected vendors to deliver required deliverables as per defined processes.
      • Design action plans based on end-customer feedback and improve course content and delivery.

    Stakeholder Engagement:

    • Collaboration:
      • Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing deliverables.
      • Liaise with the Medical department to prepare relevant and customized deliverables.

    About You:

    • Experience:

      • Over 5 years of experience in medical writing within the pharmaceuticals/healthcare industry or equivalent clinical experience.
      • At least 2-3 years of direct medical information experience in a pharmaceutical company.

    • Soft Skills:

      • Stakeholder management.
      • Effective communication skills.
      • Ability to work independently and collaboratively within a team.

    • Technical Skills:

      • Medical operational excellence.
      • Time and risk management skills.
      • Excellent technical (medical) editing and writing skills.
      • Knowledge of literature evaluation and multilevel response development.

    • Education:

      • Advanced degree in life sciences, pharmacy, or a similar discipline (e.g., PharmD, Ph.D., Master’s in Science, MBA, or equivalent).

    • Languages:

      • Excellent command of the English language (spoken and written).

    Latest Jobs

    Pharmacovigilance Associate

    Icon
    Chennai

    Senior Clinical Data Science Lead

    Icon
    Bangalore

    Senior Statistical Programmer I

    Icon
    India

    Statistical Programming Team Lead

    Icon
    Bangalore

    Senior Business Intelligence Developer

    Icon
    Bangalore

    Clinical Nurse Reviewer I

    Icon
    Bangalore

    Site Engagement Liaison

    Icon
    Mumbai

    Associate Product Safety Manager (Complaint)

    Novo Nordisk
    Beijing

    Documentation Area Specialist Ii - Ffex

    Novo Nordisk
    Remote, USA

    (Asso.) Ioccs & Medical Information Manager

    Novo Nordisk
    Remote

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Syracuse |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Republic of China :

    Beijing |

    Tokiyo :

    Osaka | Tokyo |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Salt Lake City |

    Republic of Ireland :

    Limerick | Dublin |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Remote - Europe | Remote | Remote, USA | Switzerland |

    Makkah :

    Rabigh | Riyadh | Najran | Jeddah | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |