Job Responsibilities: Senior Medical Writer
Salary: $20-30/Hour
Company: Walgreens
Location: Baton Rouge, USA
Educational Requirements: Bachelor's Degree
Activity summary:
The Senior clinical writer role is an exciting opportunity to sign up for a developing crew that is targeted on producing each actual international evidence and evidence from randomized medical trials all at the same time as advancing more various, inclusive, and equitable studies participation for all patients. Our customers are biopharmaceutical, medical tool and virtual healing agencies focused on generating proof so that it will assist regulatory decision making and fee propositions for market access expansion. The perfect candidate will serve as a senior clinical author on medical take a look at and regulatory affairs challenge groups. They'll plan and coordinate file writing sports to make certain great of completion of all writing tasks, in addition to mentor and lead less skilled scientific writers on complicated initiatives. This role reviews into the Director of Biostatistics, Walgreen’s medical Trials.
Task obligations:
- Compiles, writes, and edits clinical writing deliverables, and serves as a clinical author on challenge teams with minimal supervision.
- Affords clinical writing deliverables masking all stages of scientific research, each trials and observational studies, in numerous therapeutic areas.
- Creates writing deliverables that encompass but won't be restrained to medical look at protocols and medical protocol amendments, clinical take a look at reviews (CSRs), clinical development plans, included summary reviews, NDA and digital not unusual Technical report (eCTD) submissions, as well as clinical journal manuscripts, medical magazine abstracts, and client presentations.
- Critiques statistical analysis plans and table/determine/listing specs for suitable content, and for grammar, layout, and consistency with protocols
- Interacts with branch head and group of workers contributors in statistics control, biostatistics, regulatory affairs, and scientific affairs as necessary to provide writing deliverables.
- Serves as peer reviewer on inner review team.
- Adheres to hooked up regulatory requirements, inclusive of however now not restricted to ICH E3 tips, in addition to organisation widespread working tactics, customer requirements, and employer and/or customer permitted templates when completing clinical writing tasks, on time and on finances.
- Plays on line scientific literature searches, as requested. Maintains familiarity with modern-day enterprise practices and regulatory necessities and pointers that have an effect on scientific writing.
- Mentors and leads less experienced clinical writers on complicated initiatives, as necessary
A same-opportunity organization, together with disability/veterans
About Walgreens Boots Alliance
Walgreens Boots Alliance (Nasdaq: WBA) is a global chief in retail pharmacy, impacting millions of lives every day thru allotting drugs, and presenting reachable, high-quality care. With greater than 170 years of depended on healthcare historical past and innovation in network pharmacy, the business enterprise is meeting clients and patients wishes via its convenient retail locations, virtual platforms and fitness and beauty products.
Together with fairness approach investments, WBA has a presence in more than 25 nations, employs extra than 450,000 human beings and has greater than 21,000 stores.
WBA’s motive is to help humans across the world lead healthier and happier lives. The agency is happy with its contributions to healthy communities, a healthy planet, an inclusive place of business and a sustainable market. WBA is a player of the United countries global Compact and adheres to its concepts primarily based technique to responsible business.
WBA is covered in FORTUNE’s 2021 list of the world’s most sought after groups. That is the 28th consecutive yr that WBA or its predecessor organization, Walgreen Co., has been named to the listing.
Extra business enterprise information is available at www.Walgreensbootsalliance.Com
Fundamental qualifications
- Bachelor’s degree in life sciences, clinical sciences, English/journalism, or equal associated revel in.
- At least three years of revolutionary experience in medical and/or clinical writing consisting of 2 years as a scientific writing mission lead
- Full-size know-how of English grammar and FDA and ICH rules and tips as well as a familiarity with AMA fashion manual.
- Validated high degree of independence with powerful presentation, proofreading, interpersonal, and leadership skills and make sure a group orientated approach.
- Sturdy proficiency in phrase, Excel, PowerPoint, go with the flow Diagramming
- Capacity to illustrate a familiarity with ideas of medical research and to interpret and gift medical statistics and other complicated information.
- First rate organizational, interpersonal, written and verbal communique competencies
- Detail oriented with robust track report of multi tasking correctly on multiple tasks
- As a minimum 1 yr of direct management, oblique leadership and/or cross purposeful crew leadership.
- Inclined to travel up to/at least 10% of the time for commercial enterprise purposes (regionally and/or across the world).
Desired Qualifications
- MSc or Ph.D. with at least five years of applicable publish-degree revel in consulting, CRO, pharmaceutical or healthcare enterprise
- American clinical Writing affiliation (AMWA) certification with a uniqueness in enhancing/Writing or Pharmaceutical.
- Leadership abilities with direct line management experience
- Familiarity with medical terminologies and managed vocabularies used in healthcare statistics
- 3 years enjoy in experimental layout and medical/preclinical statistics interpretation
