Contract Medical Writer
Company Description
Katalyst Healthcares & Life Sciences is seeking entry-level candidates for multiple positions in contract research focused on clinical trials for drugs, biologics, and medical devices. We have immediate job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.
Job Description
Position: Contract Medical Writer
Location: Remote
Role Overview
The Contract Medical Writer is responsible for authoring, editing, and delivering high-quality clinical documents for regulatory submissions across assigned therapeutic areas and products in Clinical Development. This role involves collaboration with internal departments and external resources to ensure compliance with regulatory standards, Good Clinical Practice (GCP), and company protocols.
Responsibilities
Prepare complex clinical documents, including protocols, amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), and responses to health authorities.
Develop regulatory documents, specifically Common Technical Document (CTD) Module 2 and Module 5.
Collaborate with pre-clinical Subject Matter Experts (SMEs) to integrate pre-clinical data into clinical and regulatory documents.
Write and edit abstracts, manuscripts, posters, and presentations for scientific meetings and publications.
Contribute to the development and implementation of medical writing processes, templates, and style guides.
Perform additional tasks as assigned by management.
Requirements
Education: Advanced degree (PhD or PharmD) with a minimum of 5 years of medical writing experience, or a Bachelor's degree in a scientific discipline with at least 8 years of relevant experience in the pharmaceutical, biotechnology, or contract research organization (CRO) sectors.
Knowledge and Skills Needed
Proven experience in writing, editing, and formatting scientific/medical documents in accordance with FDA, EMA, and ICH guidelines.
Strong background in writing clinical protocols, CSRs, IBs, and regulatory submission documents.
Ability to critically analyze and produce clear, concise clinical regulatory documentation.
Excellent understanding of biostatistics reporting standards.
High attention to detail regarding document structure, formatting, and logical flow.
Proficiency in Microsoft Office and electronic document templates.
Strong verbal and written communication skills.
Capacity to work both independently and collaboratively in a dynamic team environment.
Strong analytical and problem-solving skills with adaptability to changing priorities.
Preferred Qualifications
Experience with IND and NDA/MAA submissions.
Broad knowledge of FDA and EMA/ICH guidelines.
Proficiency in Adobe Acrobat and Electronic Common Technical Document (eCTD) templates.
Familiarity with scientific reference tools like PubMed.
Additional Information
All information will be kept confidential in accordance with EEO guidelines.
Andra Pradesh :
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Rangpo |Tamil Nadu :
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Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | 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 | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Wilmington |Florida :
Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
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Dickinson |northeastern :
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Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
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Mexico |South Carolina :
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Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
fairmont | Georgia | United States |United States :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |WI :
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Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |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 :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |BULGARIA :
Bulgaria |Denmark :
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Finland |Hungary :
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Basel | Zurich |China :
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Dalian |Republic of China :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Cork :
Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
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Donegal |New South Wales :
Ballina | Sydney |Queensland :
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Amsterdam |Netherlands :
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Haarlem |South Holland :
Leiden |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | North York | Richmond Hill | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
Salt Lake City | Leeds | Maidenhead | United Kingdom | Stirling | Harlow | London |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |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 :
Remote | Remote - Middle East | Remote - Europe | Remote, USA | Switzerland |Bucharest :
Bucharest |Makkah :
Jeddah | Riyadh | Najran | Rabigh | Khulais | King Abdullah Economic City |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 |