• Login / Signup
    • Instagram
    youtube
    Facebook

    Medical Writer Iii

    Aequor
    3+ years
    $90/hr - $100/hr
    Princeton Junction Remote, USA
    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

    Position Title: Associate Director, Medical Writing

    Location: Remote

    Position Summary:

    The Associate Director of Medical Writing will lead key medical writing projects across various therapeutic areas, focusing on the preparation of scientific and regulatory documents related to investigational and marketed drugs and biologics. This role involves minimal supervision and includes the preparation of clinical study reports (CSRs), subject narratives, investigator brochures, protocols, briefing documents, and sections of INDs, NDAs, and BLAs. The Associate Director will leverage extensive experience in pharmaceutical medical writing and clinical development to ensure the accuracy and compliance of all regulatory documentation.

    Key Responsibilities:

    • Document Preparation: Lead the creation of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents required for regulatory submissions.
    • Submission Strategy: Contribute to the development of submission communication strategies for products.
    • Data Interpretation: Accurately interpret and summarize data from biostatistical summary tables and listings into clear, concise narrative text.
    • Internal Coordination: Liaise with internal teams, including Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations, and R&D Management, to gather necessary information and ensure timely document production.
    • Team Oversight: Manage and review the work of other medical writers, including freelance/contract writers and agencies, with support from the Director of Medical Writing.
    • Process Improvement: Foster innovation and improvements in medical writing processes and documents.
    • Other Duties: Perform additional tasks as assigned, based on project needs.

    Scope:

    • Complex Problem Solving: Use professional concepts and company objectives to resolve complex issues creatively and effectively.
    • Decision Making: Determine methods and procedures for new assignments, working on complex issues that require in-depth evaluation of data and situations.

    Physical Requirements:

    • Regularly required to stand, walk, sit, use hands to handle or feel, reach with hands and arms, and occasionally lift/move up to 20 pounds.
    • Occasional overnight travel may be required.
    • Must be able to perform duties independently from remote locations and in a standard office environment.

    Required Qualifications:

    • Education: PhD in a life science or Pharm D preferred; MS with 7+ years of relevant experience.
    • Experience: At least 3 years in medical writing within the pharmaceutical industry, focusing on regulatory document preparation and drug development processes.
    • Specific Knowledge: Experience with CNS/Neuroscience compounds is preferred.
    • Skills:
      • Strong writing skills with the ability to translate complex scientific data into clear, well-structured narratives.
      • Knowledge of US, ICH, and international regulations for regulatory document preparation and submissions.
      • Proficiency with electronic document management and publishing systems.
      • Ability to quickly assimilate information and produce high-quality summaries and reports.
      • Familiarity with Common Technical Document content templates and regulatory documentation for IND/NDA/MAA submissions.
      • Excellent command of software programs in a Windows environment, including word processing, flow diagrams, and spreadsheets.

    Preferred Qualifications:

    • Certification: AMWA certification or similar, with a focus on Pharmaceutical Writing.
    • Experience: Previous work in journalism or press publications is a plus.
    • Additional Skills: Ability to lead projects independently, manage cross-functional teams, and create a collaborative team environment.

    Languages:

    • Proficiency in English (spoken, read, written).

    To Apply:

    If you meet the qualifications and are interested in this opportunity, please submit your application today.

    Supplier FLSA Classification: N/A

    H-1B Status: Not eligible

    Job Code: Medical Writer III

    Latest Jobs

    Quality Manager

    Katalyst Healthcares & Life Sciences
    Boston

    Regulatory Affairs Associate

    Katalyst Healthcares & Life Sciences
    Boston

    Clinical Sme

    Katalyst Healthcares & Life Sciences
    Boston

    Clinical Regulatory Coordinator/ Specialist

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Clinical Regulatory Coordinator

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Associate Research Scientist Level Ii

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Senior Quality Specialist, Sequencing

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Business Analyst, Medical Affairs

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Biospecimen Research Data Management Coordinator

    Indoriv Clinical Private Limited
    Kolkata

    Clinical Documents Management Specialist

    Katalyst Healthcares & Life Sciences
    Remote, USA

    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 | 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 |

    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 | Round Lake |

    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 | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

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

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    Portugal :

    Lisbon |

    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 | Ulm |

    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 |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

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

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | Harlow | London |

    Jakarta :

    Jakarta |

    Republic of Ireland :

    Dublin | Limerick |

    Israel :

    Netanya | Kfar Saba | Tel Aviv |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

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

    Makkah :

    Jeddah | Rabigh | Najran | Khulais | Riyadh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |