• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Associate - Scientific Writing

    Indegene
    4-6 years
    Not Disclosed
    Bangalore
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: MBBS/PhD/MDS/BDS/MPharm/PharmD 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

    Lead Medical Writer

    EDUCATION:

    • MBBS/PhD/MDS/BDS/MPharm/PharmD

    EXPERIENCE:

    • 4 to 6 years of experience in writing clinical and regulatory documents supporting global filings (CTD Module 2 and Module 5).

    ROLE PURPOSE:
    The Lead Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio, including training junior writers.

    SKILLS:

    • Experience in authoring a broad set of clinical document types, especially with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs).
    • Excellent writing and editing skills, with the ability to follow defined processes and templates.
    • Lead cross-functional teams to draft scientific and medical content that addresses data interpretation, product claims, and internal/external questions.
    • Understanding of the clinical development process, from program planning to submission, including clinical trial design.
    • Strong communication, time management, organizational, and interpersonal skills.
    • Ability to manage tasks, responsibilities, and timing for efficient document delivery.
    • Ability to adapt and work across therapeutic areas to support resource needs and business continuity.
    • Expertise in MS Word and familiarity with document management systems and tools.
    • Ability to train junior writers on templates, guidelines, and tools.

    KNOWLEDGE REQUIREMENTS:

    Scientific Knowledge:

    • Strong knowledge of regulatory guidelines/requirements, including those from the European Union and the United States.
    • Ability to interpret data and apply scientific knowledge in regulatory document writing (IB, protocols, amendments, CSR, clinical summaries).
    • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy, and therapeutic area science.
    • Understanding of medical practices related to disease treatments and procedures.
    • Experience writing protocols, amendments, CSRs, and CTD summary documents.

    Technology Skills:

    • Expertise in MS Word functionality for authoring.
    • Experience with document management systems and workflow management for eApproval/signatures.
    • Flexibility in adapting to new tools and technologies.

    RESPONSIBILITIES:

    • Prepare and review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents for investigational drugs.
    • Apply lean authoring principles and structured content management in document development.
    • Coordinate activities for document review, consensus meetings, quality control, and document finalization.
    • Develop and maintain project plans.
    • Act as an active member of cross-functional teams, representing medical writing.
    • Organize and facilitate document kick-off meetings and ensure team alignment on standard content.
    • Participate in the orientation and coaching of junior team members.
    • Conduct literature searches and ensure documents meet regulatory requirements.
    • Research regulatory requirements and remain current in the regulatory landscape.
    • Share lessons learned, best practices, and ensure compliance with company training and reporting.

    Latest Jobs

    Cell Therapy Qa Manager

    Takeda Pharmaceutical
    Boston

    Business Account Manager

    Takeda Pharmaceutical
    Delhi

    Director, Global Alliance Management, R&D, Oncology Therapeutic Area

    Takeda Pharmaceutical
    Boston

    Infection Preventionist (Rn)

    National Health Care Associates Inc.
    Rome

    Pharmacist Clinician Anticoagulation/Full-Time In Santa Fe, Nm

    Christus Health
    Santa Fe

    Jpc - 176180 - Drug Safety Associate In Connecticut (Remote)

    Trioptus
    Stanford

    Sme - Process Specialist

    Cognizant
    Plano

    Client Relationship Manager, Life Sciences (Raleigh, Nc)

    Cognizant
    Raleigh

    Client Relationship Manager - Life Sciences (Minneapolis)

    Cognizant
    Minneapolis and St. Paul, Minnesota.

    Life Science Qa Test Program Manager - Associate Director

    Cognizant
    Boston Chicago

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Pydibimavaram | 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 | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    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

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

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

    Arkansas :

    Fort Smith |

    California :

    Alameda | Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | Menlo Park | 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 | South San Francisco | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Enfield | Groton | Storrs |

    D.C :

    Washington |

    Florida :

    Clearwater | Coral Gables | Daytona Beach | Gainesville | Jacksonville | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence |

    Kenlucky :

    Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Andover | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | St. Louis |

    Nevada :

    Las Vegas |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | 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 Mexico :

    Santa Fe |

    New York :

    Albany | Biddle | Buffalo | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Macedonia |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Roseburg | Salem | Springfield |

    Pennsylvania :

    Ambler | Collegeville | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bothell | Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

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

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    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

    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

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Argentina & Australia & Austria & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Greece & Indonesia & Ireland & Israel & Italy & Japan & Kazakhstan & Korea & Netherland & Philippines & Portugal & Remote & Saudi Arabia & Singapore & South Afrcia & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Austria :

    Austria |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Canada :

    Canada |

    Ontario :

    North York | Richmond Hill |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | Harlow | London | Maidenhead | Stirling | Leeds |

    Estonia :

    Estonia |

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Lyon | Paris |

    Greece :

    Greece |

    Jakarta :

    Jakarta |

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Waterford | Limerick |

    Israel :

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

    Italy :

    Italy |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Remote :

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

    Makkah :

    Jeddah | Rabigh | Riyadh | Khulais | Najran |

    Singapore :

    Singapore |

    South Africa :

    Midrand |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Dubai :

    Dubai |