Position Overview:
We are seeking a highly skilled regulatory medical writer to provide exceptional writing services for both internal and external clients. The successful candidate will offer technical consultation and substantive advice on strategy, regulations, and industry best practices, showcasing expertise in specific therapeutic areas. You will effectively manage medical writing projects to deliver quality products within agreed timelines and collaborate with clients to foster effective communication and operational excellence.
Independent Writing and Editing: Research, write, and edit peri-/post-approval clinical study reports, study protocols, informed consent forms, and other regulatory documents. Support the development of complex documents, including investigator brochures (IBs) and sections of INDs, NDAs, and CTDs.
Project Management: Oversee all aspects of project planning and execution without supervision. This includes developing project timelines, standards, budgets, forecasts, and contract modifications. Liaise with functional units such as project management, clinical, QA, data management, biostatistics, and regulatory teams. Identify and escalate any out-of-scope activities promptly while proposing solutions.
Problem Solving: Tackle diverse problems that require the evaluation of identifiable factors through data analysis.
Client Interaction: Interact with internal and external stakeholders on significant matters, coordinating efforts across functional areas. Build and maintain relationships with senior personnel in your area of expertise.
Autonomy in Work: Operate with minimal instruction on daily tasks, demonstrating sound judgment in selecting methods and techniques for obtaining solutions.
Representation: Serve as the primary contact for the department on projects, participating in project launch meetings, review sessions, client audits, bid defenses, and capability presentations. Foster client relationships and take the initiative in client interactions. Assist in business development, budget creation, and proposal development.
Educational Background: Bachelor’s degree in a scientific discipline or equivalent relevant qualification; an advanced degree is preferred.
Experience: Previous writing experience that provides the knowledge and skills necessary for the role (approximately 2-5 years) or an equivalent combination of education, training, and experience. Experience in the pharmaceutical or CRO industry is preferred.
Certifications: Additional qualifications in medical writing (e.g., AMWA, EMWA, BELS, RAC) are advantageous.
Regulatory Knowledge: Significant understanding of global, regional, and national document development guidelines, with in-depth knowledge in specialty areas such as therapeutics, regulatory submissions, and healthcare communications.
Technical Skills: Excellent computer proficiency, including familiarity with client templates and document management systems (e.g., Excel, Outlook).
Communication: Exceptional written English skills with the ability to effectively document information. Produce well-organized, error-free documents, emails, and communications tailored to the audience’s needs.
Analytical Aptitude: Ability to manipulate and format numerical data to provide insights and evidence. Analyze complex issues, identify information gaps, and generate effective solutions.
Project Management: Capable of creating and managing effective project plans that align with overall objectives. Guide project team members and monitor progress in an organized manner to ensure timely results.
Professional Judgment: Demonstrate sound judgment in analyzing and resolving inquiries and issues.
Conflict Resolution: Facilitate resolution of conflicts among team members and clients through effective listening and understanding of the root causes, achieving agreement on action plans, and ensuring successful outcomes.
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 |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 |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | 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 |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 | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |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 |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |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 |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Osaka | Tokyo |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London |Republic of Ireland :
Dublin | Limerick |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote | Remote, USA | Remote - Europe |Makkah :
Rabigh | Najran | Riyadh | Khulais | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |