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.
Gujarat :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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Rostock |Saarland :
Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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