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Medical Technical Writer - 509283
Ridgefield, CT
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Medical Technical Writer, Remote. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations.
* Accountable for Patient Narrative process and final delivery including coordinating the strategy, overseeing the process, managing timelines with cross-functional teams, and interfacing and overseeing the vendor to ensure timely and successful document finalisation.
* Responsible for the preparation of relevant content for global clinical documents (CTPs, IBs, CTRs, ICFs, or other relevant clinical documents) including the planning and set up in the document management system for authoring teams, the planning and strategy for document development, and the overseeing of timelines. Requires proactive and continuous cross-functional coordination with functional areas outside of GMW as well as external vendors or CROs to ensure timely and successful document finalisation.
* Manages and is accountable for all technical steps for document development. This may include the set-up, organization, and standard content management for various document types as well as overseeing and managing the publishing and archiving activities for global clinical documents managed by GMW. The Medical Technical Writer serves as the interface between GMW and Global Regulatory Operations.
* Ensures quality of the deliverables that are outsourced to vendors/CROs that are writing clinical trial reports or other clinical regulatory documents and acts as the interface to systems that are not accessible to external vendors.
* Develop in-depth knowledge in the technical writing area and stays on top of new developments and industry standards. Understand and utilize document formatting and writing conventions and standards. Exchange knowledge with Global Medical Writers and ensure new ideas are integrated and implemented within GMW.
Must work in EST time zone. The team is in Germany. They have other teams in China, Germany, Japan, and US.
Therapeutic areas working on: CMR, Immunology, Oncology, Inflammation, CNS.
Duties:
Supporting medical writers in global writing team
Setting up documents on the electronic document repository.
Supporting project management activities with other team members.
Working on writing portions and finalization and archive documents that the document underwent.
The person would be writing, formatting, and editing documents such as Clinical Trail Documents, Clinical Trial protocols, Clinical Trial reports, Clinical Trial brochures, summary documents required for submission.
Must Haves
Strong project management skills.
Strong MS word skills.
Someone with proofreading experience or BG with Technical writing or medical writing would work.
Good Proactive communicator.
Attention to detail.
Veeva vault is plus (Not working currently but will be transitioning to it Nov.).
Pharma and Med. Device Industry exp. works best here but Open to any industry if they have the right exp.
EXPERIENCE
Skills:
The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement. Additional complexity is introduced by external providers and awareness of cultural diversity. The job requires handling numerous complex tasks simultaneously. Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements. Deep knowledge of international writing standards and conventions and regulatory writing. Sound knowledge of safety reporting and regulatory requirements. Ability to proactively identify problems and initiate improvements. Understanding of the business impact of timelines for clinical documents. Excellent written and verbal English skills, sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity. Places a high priority on regulatory compliance and quality. Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers. Ability to manage parallel tasks and variable workload. Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity.
EDUCATION
Masters degree with a minimum of 2-3 years or a bachelors degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other
Open to PhD but would want to ask if they would be interested in this kind of role.
Master's 2-3 years
Bachelor's 3-5 years
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
We are currently searching for a skilled professional to join a well-known client's team as a Medical Technical Writer, Remote. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations.
* Accountable for Patient Narrative process and final delivery including coordinating the strategy, overseeing the process, managing timelines with cross-functional teams, and interfacing and overseeing the vendor to ensure timely and successful document finalisation.
* Responsible for the preparation of relevant content for global clinical documents (CTPs, IBs, CTRs, ICFs, or other relevant clinical documents) including the planning and set up in the document management system for authoring teams, the planning and strategy for document development, and the overseeing of timelines. Requires proactive and continuous cross-functional coordination with functional areas outside of GMW as well as external vendors or CROs to ensure timely and successful document finalisation.
* Manages and is accountable for all technical steps for document development. This may include the set-up, organization, and standard content management for various document types as well as overseeing and managing the publishing and archiving activities for global clinical documents managed by GMW. The Medical Technical Writer serves as the interface between GMW and Global Regulatory Operations.
* Ensures quality of the deliverables that are outsourced to vendors/CROs that are writing clinical trial reports or other clinical regulatory documents and acts as the interface to systems that are not accessible to external vendors.
* Develop in-depth knowledge in the technical writing area and stays on top of new developments and industry standards. Understand and utilize document formatting and writing conventions and standards. Exchange knowledge with Global Medical Writers and ensure new ideas are integrated and implemented within GMW.
Must work in EST time zone. The team is in Germany. They have other teams in China, Germany, Japan, and US.
Therapeutic areas working on: CMR, Immunology, Oncology, Inflammation, CNS.
Duties:
Supporting medical writers in global writing team
Setting up documents on the electronic document repository.
Supporting project management activities with other team members.
Working on writing portions and finalization and archive documents that the document underwent.
The person would be writing, formatting, and editing documents such as Clinical Trail Documents, Clinical Trial protocols, Clinical Trial reports, Clinical Trial brochures, summary documents required for submission.
Must Haves
Strong project management skills.
Strong MS word skills.
Someone with proofreading experience or BG with Technical writing or medical writing would work.
Good Proactive communicator.
Attention to detail.
Veeva vault is plus (Not working currently but will be transitioning to it Nov.).
Pharma and Med. Device Industry exp. works best here but Open to any industry if they have the right exp.
EXPERIENCE
Skills:
The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement. Additional complexity is introduced by external providers and awareness of cultural diversity. The job requires handling numerous complex tasks simultaneously. Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements. Deep knowledge of international writing standards and conventions and regulatory writing. Sound knowledge of safety reporting and regulatory requirements. Ability to proactively identify problems and initiate improvements. Understanding of the business impact of timelines for clinical documents. Excellent written and verbal English skills, sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity. Places a high priority on regulatory compliance and quality. Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers. Ability to manage parallel tasks and variable workload. Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity.
EDUCATION
Masters degree with a minimum of 2-3 years or a bachelors degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other
Open to PhD but would want to ask if they would be interested in this kind of role.
Master's 2-3 years
Bachelor's 3-5 years
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3 to 5 years
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