• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Medical Writer (Clinical Pharmacology)

    Propharma
    5+ years
    Not Disclosed
    United States
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Senior Medical Writer
    Company: ProPharma Group
    Location: Remote
    Position Type: Full-Time

    About ProPharma Group

    For the past 20 years, ProPharma has been at the forefront of improving patient health by empowering biotech, pharmaceutical, and medical device organizations to confidently bring new therapies and innovations to market. As the world’s largest Research Consulting Organization (RCO), ProPharma offers comprehensive, customizable solutions across the product lifecycle. With deep expertise in regulatory sciences, clinical research, pharmacovigilance, quality & compliance, and more, ProPharma accelerates the success of its clients' high-profile drug and device programs.

    Position Overview

    ProPharma is seeking a Senior Medical Writer to lead the creation of high-quality medical writing deliverables. This role requires a strong focus on regulatory standards, quality, and efficiency, as well as the ability to manage multiple projects in various therapeutic areas. The Senior Medical Writer will work with minimal supervision, support clients directly, and mentor less experienced writers.

    Key Responsibilities

    • Authoring Medical Documents:

      • Write and edit clinical, safety, regulatory, device, and diagnostic documents (e.g., protocols, study reports, patient narratives, regulatory submissions like IND, NDA, BLA, PBRER).

    • Client Interaction:

      • Manage client expectations, lead team meetings, and communicate directly with clients regarding project timelines and deliverables.

    • Collaboration & Mentorship:

      • Collaborate with cross-functional teams (clinical operations, biostatistics, etc.) and mentor less experienced medical writers.

    • Quality Control:

      • Review statistical analysis plans, table/figure/listing shells, and other documents for accuracy, consistency, and adherence to guidelines.

    • Project Management:

      • Manage multiple deliverables/projects simultaneously, track timelines, and ensure on-time, within-budget delivery.

    • Regulatory Knowledge:

      • Stay updated on current industry practices, regulatory requirements, and guidelines related to medical writing.

    • Process Improvement:

      • Participate in departmental initiatives aimed at improving efficiency and quality.

    Necessary Skills and Abilities

    • Clinical Research Expertise:

      • Advanced knowledge of clinical research principles, FDA regulations, and other relevant guidelines.

    • Project Management:

      • Strong organizational, time-management, and communication skills.

    • Writing Proficiency:

      • Expert MS Word skills (tables, graphs, figures) and familiarity with AMA style.

    • Collaboration:

      • Experience building relationships and collaborating with key stakeholders.

    • Proactive Problem-Solving:

      • Ability to identify inefficiencies and suggest improvements to management.

    Educational Requirements

    • Bachelor’s degree or higher in a medical or scientific discipline.

    Experience Requirements

    • Minimum 5 years of experience in clinical and/or regulatory writing for drugs, biologics, and/or medical devices/diagnostics.

    • Experience in contract research organizations, pharmaceutical companies, or biotechnology firms preferred.

    Additional Information:

    • ProPharma fosters a workplace of diversity, equity, and inclusion, encouraging employees to be their authentic selves and contribute to an innovative, collaborative environment.
    • #LI-Remote
    • Note: ProPharma does not accept unsolicited resumes from recruiters or third parties.

    How to Apply:

    Interested candidates should apply directly through ProPharma’s career portal.

    Let me know if you need further assistance!

    Latest Jobs

    Associate Director, Chemical Development And Drug Substance Manufacturing

    Cytokinetics
    South San Francisco

    Associate Director, Cmc Analytical Chemistry

    Cytokinetics
    South San Francisco

    Executive Director, Fp&A

    Cytokinetics
    South San Francisco

    Associate Director, Clinical Data Management - External Data Solutions

    Cytokinetics
    South San Francisco

    Associate Director Of Regulatory Affairs, Advertising And Promotion

    Cytokinetics
    South San Francisco

    Associate Director, Us Patient Marketing

    Cytokinetics
    South San Francisco

    Contract - Sr Clinical Trial Manager (Ctm)

    Cytokinetics
    South San Francisco

    Senior Director, Clinical Supply Chain

    Cytokinetics
    South San Francisco

    Director, Drug Safety Physician

    Cytokinetics
    South San Francisco

    Senior Director, Regulatory Affairs

    Cytokinetics
    South San Francisco

    Pharma Jobs in India

    Andra Pradesh :

    Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Pondicherry (Puducherry) :

    Pondicherry (Puducherry) |

    Punjab :

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

    Rajasthan :

    Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |

    Sikkim :

    Rangpo |

    Tamil Nadu :

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

    Uttar Pradesh :

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

    Uttarakhand :

    Dehradun | Halifax | Nainital | Rishikesh | Roorkee |

    West Bengal :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

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

    Arkansas :

    Fort Smith |

    California :

    Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |

    Colorado :

    Boulder | Denver | Westminster |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Brooksville | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |

    Georgia :

    Atlanta | Augusta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Kansas City | Lawrence | McPherson |

    Kentucky :

    Edgewood | Ft MItchell | Louisville | Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Baton Rouge | Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maine :

    Bangor | Brewer |

    Maryland :

    Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |

    Massachusetts :

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

    Michigan :

    Detroit | Houghton Lake | Macomb | Southfield |

    Minnesota :

    Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh | Virginia |

    New Hampshire :

    Lebanon | Macon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | 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 :

    Albuquerque | Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Oeiras | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Knoxville | Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |

    United states :

    fairmont | Georgia | Keene | OH | United States |

    United States :

    Hawai | kentucky | Sylmar | Woonsocket |

    Virginia :

    Blacksburg | Charlottesville | Falls Church | Mechanicsville |

    Washington :

    Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Appleton | Pleasant Prairie | Portage | Waukesha |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    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 :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Belgium :

    Wavre |

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in Ireland

    Carlow :

    Carlow |

    Cork :

    Brinny | Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Meath :

    Dunboyne |

    Republic of Ireland :

    Cork | Dublin | Limerick | Waterford |

    Tipperary :

    Ballydine |

    Ulster :

    Donegal |

    Pharma Jobs in China

    China :

    China | Quarry Bay |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Australia

    Melbourne :

    South Yarra |

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    North Brabant :

    Breda |

    South Holland :

    Leiden |

    Pharma Jobs in England

    North Yorkshire :

    Harrogate |

    Oxfordshire :

    Witney |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Flemish Brabant :

    Zaventem |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    Mississauga | Renfrew | Richmond Hill | Uxbridge | North York |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    Estonia :

    Estonia | Tartu |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Koropi | Athens |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

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

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Saitama | Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote | Remote - Europe | Remote - Middle East | Remote, USA | Remote - South America (Latin Americal) | Switzerland | Remote - Africa |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | Khulais | Jeddah | King Abdullah Economic City | Rabigh | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |