PPD Sr Med Writer in Waltham, Massachusetts
SENIOR MEDICAL WRITER, COA/PRO (remote capable)
*We are looking to fill this role in North America, UK or Europe.
Evidera is one of the preeminent commercial entities analyzing effectiveness, establishing evidence, and substantiating value of health treatments within the global health industry. Through its market leading portfolio of health economics, outcomes research, market access, data analytics and epidemiology services, it partners with life sciences organizations worldwide to optimize the market access and commercial success of their products. Evidera’s COA Analytics team designs and implements statistical analyses of COA/ patient-reported outcomes (PRO) data from clinical studies to support pharmaceutical product review by regulatory and/or health technology assessment (HTA) agencies, and effectively communicates the COA/PRO values of the products to different audiences. We have built strong relationships and developed an outstanding reputation with a core group of bio-pharmaceutical clients for our ability to help them shape and execute the statistical analyses of COA/PRO data to ensure successful regulatory and reimbursement submissions.
We are looking for a highly experienced senior medical writer to join our COA Analytics team. The position will be responsible for developing analysis reports, abstracts, posters, and manuscripts for the COA projects in collaboration with the project leader and other project team members.
_Essential Duties and Responsibilities (other duties may be assigned):_
The successful candidate will be part of multi-disciplinary research teams to provide expertise in scientific/medical writing and product value communication. Responsibilities include:
- Acting as the lead writer on COA project teams
- Independently researching and writing fully-referenced content for regulatory and/or HTA review, based on evidence/findings obtained from the statistical analyses of COA/PRO data and published literature.
- Interacting with internal and external clients to draft dissemination materials (i.e., abstracts, posters, and manuscripts) for communicating the COA/PRO value messages of the products, including the handling of submission of the dissemination materials to scientific conferences and/or journals for review and any issue occurring during the review process.
- Assisting project leader in developing slide deck in PowerPoint to communicate the findings of the analyses to the clients
- Editing, quality assurance, and formatting project-related documents developing by other project team members
- Workload management to meet internal and client-driven deadlines
_Education, Professional Skills & Experience:_
- 2-3 years consultancy/pharmaceutical/CRO experience in medical/scientific writing role.
- Advanced degree in life sciences, health economics, or a clinical discipline is preferred, e.g., PhD, PharmD, MD, MPH, MS. Experienced candidates with a BS/BA are also welcome to apply.
_Personal Skills & Competencies:_
The successful candidate is a highly motivated, detail-oriented, and organized self-starter who works well independently and on teams. Enthusiasm for a professional writing career and excellent verbal and written communication skills are essential.
Key competencies include:
Experienced in medical/scientific writing with a focus on accuracy and quality
Ability to understand and clearly convey complex clinical, humanistic, economic, and commercial information, after receiving appropriate training on new content areas
Research and analysis skills, e.g., ability to undertake reviews of the scientific literature
Exquisite attention to detail
Knowledge of the pharmaceutical industry and drug development process
Familiarity with clinical trials and basic biomedical statistics
Comfort in a client-facing role
Familiarity with Microsoft Word, PowerPoint, and Excel
Strong time management skills and ability to work simultaneously on multiple projects
It is helpful, but not essential, to have:
Understanding of PRO and health-related quality of life (HRQoL) measures and instruments
Understanding of market access and health economics
Experience with bibliographic referencing software
Evidera is a business within in Pharmaceutical Product Development, LLC (PPD)a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive and understand information & ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary for typical working hours
- Ability to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- May require occasional travel
Evidera offers a great mix of compensation and benefits options to show you how valuable you are to the organization.
Some of our perks include:
- Highlycompetitive salary and bonusstructure
- Generous benefits package, including healthcare, dental, vision and paid time off to spent with your friends and family
- Flexible working environment by offeringfully remoteworkfor most of our positions, to support work-life balance
- Clear opportunities forgrowth and career progression. We offer multiple Learning & Development programs, coaching and mentoring trainings, career planning and discussions to help you grow as a professional.
- Access to EmployeeWell-being programsand services. We value your emotional health and offer a variety of programs to support yourmental healthcare.
- Collaborative working environment with focus onDiversity and Inclusion. At Evidera, we respect one another and recognize that our diversity makes our business stronger. We strive to be an inclusive organization where colleagues can be their authentic selves and grow their careers.
- Global exposure: Opportunity to work on multiple projects with some of the industry’s leading researchers around the globe.
- Smooth onboardingprocess with your own dedicated onboarding specialist and a working buddy to help you navigate through your first few weeks thus ensuring great start to your new role.
Our 4i Values:
Our 4i Values are critical components in accomplishing our mission. These values guide us and, ultimately, define us.
Integrity – Innovation – Intensity – Involvement
If you resonate with them and wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!*
/*only shortlisted candidates will be contacted/
Job: *Medical Writing
Organization: *US BU
Title: Sr Med Writer
Location: MA-Waltham-Evidera Waltham MA
Requisition ID: 222124
Other Locations: CA-CA-Canada-Home-Based Support Canada ON, GB-GB-London-London UK, CA-CA-Canada-Home-Based Support Canada QC
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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