Lifelancer
Job Title:
Senior Medical Writer Job Location:
Rockville MD USA Job Location Type:
Remote Job Contract Type:
Fulltime Job Seniority Level:
MidSenior level Overview
Senior Medical Writer
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago becoming one of the primary clinical research providers to the US government before expanding into publicprivate partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy vaccines and infectious diseases ophthalmology rare diseases and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research come join us!
Primary Purpose
The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies and to support other clinical communication efforts including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peerreviewed journals.
Responsibilities
Prepares Investigational New Drug (IND) applications amendments annual reports New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA) and other documents to support global product development Leads the development and authoring of clinical protocols clinical study reports investigator brochures and clinical summaries in support of regulatory filings in collaboration with clinical study teams Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peerreviewed journals including direct collaboration with internal and external authors Lead the development of clientdirected programs and projects to ensure that highquality outputs are delivered within agreed timelines and within budget Organizes conducts and leads crossfunctional document development meetings Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problemsolving ability Represents medical writing on study/project teams and contributes to program strategy through collaborative engagement with personnel from other clinical disciplines regulatory affairs and scientific departments Lead or participate in development of medical writing processes and infrastructure development Performs other duties as assigned Complies with all policies and standards
Qualifications
BS/BA degree in a scientific or healthrelated field required; Masters PharmD or PhD preferred At least 5 years of experience or equivalent in clinical and regulatory submissions writing in the pharmaceutical biotech device medical communications or CRO industries. Demonstrated ability to produce clear concise and effective written and verbal communications describing scientific and clinical data in English Understanding of clinical product development clinical research clinical study design biostatistics medical terminology research methodology the regulatory environment including FDA/ICH guidelines and principles of GXP/ICH/CTD and other global standards Strong emphasis on medical terminology and/or research methodology Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final highquality document Independently motivated with good problemsolving skills allowing analysis synthesis and compilation of data from a broad range of disciplines Wellorganized with demonstrated ability to prioritize tasks work simultaneously on multiple projects and complete highquality documents according to timelines without compromising document quality Ability to work in a fastpaced cohesive collaborative teamoriented work environment
Why work at Emmes
At Emmes your actions and hard work will have a direct impact on public health initiatives both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares
community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce including:
Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter
@EmmesCRO
Find us on LinkedIn
Emmes
The Emmes Company LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin political affiliation sexual orientation gender identity marital status disability protected veteran status genetic information age or other legally protected characteristics.
Lifelancer (
) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link. /jobs/view/8810e6d7defae3126225ca9b58e5acd0
Apply on Lifelancer Platform
Senior Medical Writer Job Location:
Rockville MD USA Job Location Type:
Remote Job Contract Type:
Fulltime Job Seniority Level:
MidSenior level Overview
Senior Medical Writer
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago becoming one of the primary clinical research providers to the US government before expanding into publicprivate partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy vaccines and infectious diseases ophthalmology rare diseases and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research come join us!
Primary Purpose
The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies and to support other clinical communication efforts including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peerreviewed journals.
Responsibilities
Prepares Investigational New Drug (IND) applications amendments annual reports New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA) and other documents to support global product development Leads the development and authoring of clinical protocols clinical study reports investigator brochures and clinical summaries in support of regulatory filings in collaboration with clinical study teams Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peerreviewed journals including direct collaboration with internal and external authors Lead the development of clientdirected programs and projects to ensure that highquality outputs are delivered within agreed timelines and within budget Organizes conducts and leads crossfunctional document development meetings Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problemsolving ability Represents medical writing on study/project teams and contributes to program strategy through collaborative engagement with personnel from other clinical disciplines regulatory affairs and scientific departments Lead or participate in development of medical writing processes and infrastructure development Performs other duties as assigned Complies with all policies and standards
Qualifications
BS/BA degree in a scientific or healthrelated field required; Masters PharmD or PhD preferred At least 5 years of experience or equivalent in clinical and regulatory submissions writing in the pharmaceutical biotech device medical communications or CRO industries. Demonstrated ability to produce clear concise and effective written and verbal communications describing scientific and clinical data in English Understanding of clinical product development clinical research clinical study design biostatistics medical terminology research methodology the regulatory environment including FDA/ICH guidelines and principles of GXP/ICH/CTD and other global standards Strong emphasis on medical terminology and/or research methodology Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final highquality document Independently motivated with good problemsolving skills allowing analysis synthesis and compilation of data from a broad range of disciplines Wellorganized with demonstrated ability to prioritize tasks work simultaneously on multiple projects and complete highquality documents according to timelines without compromising document quality Ability to work in a fastpaced cohesive collaborative teamoriented work environment
Why work at Emmes
At Emmes your actions and hard work will have a direct impact on public health initiatives both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares
community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce including:
Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter
@EmmesCRO
Find us on LinkedIn
Emmes
The Emmes Company LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin political affiliation sexual orientation gender identity marital status disability protected veteran status genetic information age or other legally protected characteristics.
Lifelancer (
) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link. /jobs/view/8810e6d7defae3126225ca9b58e5acd0
Apply on Lifelancer Platform